BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 6700074 · Received July 11, 2017

    Report

    Report Number
    3008382007-2017-21842
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    July 7, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH SELECT SIMPLE METER HAD READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE STARTED ON (B)(6) 2017. FROM THIS DATE THROUGH UNTIL (B)(6) THE PATIENT OBTAINED POST-PRANDIAL BLOOD GLUCOSE RESULTS IN THE RANGE OF ¿110-159MG/DL¿ AND FASTING BLOOD GLUCOSE RESULTS OF ¿95-115MG/DL¿. THE PATIENT WAS ADVISED THAT THEIR RESULTS SHOULD BE ¿<130MG/DL¿ FOR POST-PRANDIAL AND ¿<95MG/DL¿ FOR FASTING. THE PATIENT DID NOT TAKE ANY MEDICATION IN ORDER TO MANAGE THEIR DIABETES BUT AS A RESULT OF THESE ELEVATED RESULTS THE PATIENT WAS PUT ON AN INSULIN REGIMEN ¿ THEY BEGAN TAKING 5 UNITS OF A ¿MIXTARD 30 FLEXPEN¿ ON (B)(6) 2017. THE FOLLOWING DAY, (B)(6) 2017, THE PATIENT DEVELOPED SYMPTOMS OF ¿BREATHLESS, DROWSINESS, UNEASINESS AND WEAKNESS¿. THE PATIENT DID NOT SEEK ANY TREATMENT INITIALLY, BUT THE FOLLOWING DAY, (B)(6) 2017, THE PATIENT VISITED THEIR DOCTOR WHERE THEY WERE ADVISED TO STOP TAKING THE INSULIN WHICH WAS PRESCRIBED. THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON A CALIBRATED LABORATORY DEVICE DURING THIS VISIT AND THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿96MG/DL¿ (FASTING) AND ¿108MG/DL¿ (POST-PRANDIAL). NO FURTHER TREATMENT WAS REQUIRED. AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481935 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening