Medical devices regulator issues alert on faulty glucose test strips
People with diabetes who use particular blood glucose test strips should stop using them and seek an alternative as soon as possible says the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a manufacturing fault which could lead to a risk of them giving false low blood glucose results.
The manufacturer, Nipro Diagnostics, found an issue with the packaging meaning that test strips in specific lots are not sealed properly. This can affect how the strips measure blood glucose levels and could lead to undetected high blood glucose (hyperglycaemia) which can have serious health implications.
People using these test strips, which are used in TRUEresult, TRUEresult twist, and TRUEtrack blood glucose meters, are asked to check if they use affected blood glucose test strips with the lot numbers below.
| Product name | Item number | Lot number | Exp. Date |
| TRUEresult PQQ | E3I24‐81‐OTC | PS2190IGB | 31‐Dec‐17 |
| TRUEresult PQQ | E3I24‐81‐OTC | PS2319IGB | 18‐May‐18 |
| TRUEresult PQQ | E3I24‐81‐OTC | PS2322IGB | 19‐May‐18 |
| TRUEresult PQQ | E3I24‐81 | PS2190IGB | 31‐Dec‐17 |
| TRUEresult PQQ | E3I24‐81 | PS2319IGB | 18‐May‐18 |
| TRUEresult PQQ | E3I24‐81 | PS2322IGB | 19‐May‐18 |
| TRUEresult PQQ | E3I24‐81 | PS2407IGB | 16‐Jul‐18 |
| TRUEtrack | A3I24‐81 | RS4645IGB | 30‐Sep‐17 |
| Product name | Item number | Kit lot number | Exp. Date |
| TRUEresult PQQ | E4I24‐81 | KS1228 | 31‐Mar‐18 |
| TRUEresult PQQ | E4I24‐81 | KS1229 | 31‐Mar‐18 |
| TRUEresult PQQ | E4I24‐81 | KS1230 | 31‐Mar‐18 |
| TRUEresult PQQ | E4I24‐81 | KS1241 | 31‐Mar‐18 |
MHRA has issued a Medical Device Alert (MDA) to healthcare professionals.
John Wilkinson, MHRA’s Director of Medical Devices said
It’s important that you check your test strips. Stop using them if they are in the affected lots and, if necessary, seek alternatives as soon as possible. You can contact the manufacturer on 0800 08 588 08 to return affected strips.
If you have any questions about your blood glucose readings you should speak with your diabetes care team.
We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.
Simon O’Neill, Director of Health Intelligence at Diabetes UK said:
Ensuring the correct level of blood sugar is vitally important in the management of diabetes.
We welcome this action taken by MHRA to ensure people can be sure of correctly testing their blood glucose.
People using these test strips should return them to the manufacturer. If they have any concerns about their blood sugar levels they should talk to their diabetes care team.
Background
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes NIBSC and CPRD. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.
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