There was an allegation of questionable glucose results from accu-chek inform ii meters.At 16:44, the result from meter serial number (b)(4) was 512 mg/dl and was obtained from the left index finger.At 16:46, the result from meter serial number (b)(4) was 346 mg/dl and was obtained from the left index finger.At 16:49, the result from meter serial number (b)(4) was 109 mg/dl and was obtained from the left index finger.At 16:50, the result from meter serial number (b)(4) was 171 mg/dl.At 17:24, the result from a siemens dimension exl analyzer was 123 mg/dl.The nurse reported that the patient was eating fruit with her fingers.Treatment was provided based on the laboratory result.
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Quality controls were performed every 24 hours and passed.The customer returned >12 strips.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.The returned vial hinge on the flip-top cap was partially broken off.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation is ongoing.
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