BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 3080442 · Received April 26, 2013

    Report

    Report Number
    3008382007-2013-09240
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 11, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K072543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT IN TURKEY CONTACTED LIFESCAN TO REPORT THE ONE TOUCH SELECT METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2013, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON (B)(6) 2013, AT 12:00 PM, THE PATIENT OBTAINED THE PRE-MEAL BLOOD GLUCOSE READINGS OF 250 MG/DL AND 244 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WERE INACCURATELY HIGH COMPARED TO HIS EXPECTED VALUE OF 110 MG/DL. BASED ON THESE READINGS, THE PATIENT TOOK AN ADDITIONAL 6.0 UNITS NOVOMIX FLEXPEN 30 INSULIN, 16.0 UNITS IN TOTAL, AS ADVISED BY HIS HCP. THE PATIENT ALSO TOOK THE ACTION OF CONSUMING LESS FOOD. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND SWEATING. WHILE SYMPTOMATIC, THE PATIENT REPORTEDLY OBTAINED THE BLOOD GLUCOSE READINGS OF 250 MG/DL AND 244 MG/DL ON THE REPORTED METER. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD, AND FELT BETTER AFTERWARDS. HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON ELEVATED METER READINGS, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE HIS SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182709 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3326561

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R