BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 3178831 · Received June 20, 2013

    Report

    Report Number
    3008382007-2013-17906
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    June 19, 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 CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH SELECT METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN DURING THE LATE EVENING A COUPLE WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿160, 260 AND 300 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). BASED ON THE ALLEGED RESULTS, THE PATIENT ADMINISTERED SELF AN INCREASED DOSE OF INSULIN (AMOUNT NOT SPECIFIED). EARLIER THAT SAME EVENING, THE PATIENT ALSO REPORTED EXERCISING MORE THAN USUAL. ABOUT 4 HOURS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT A LOW BLOOD GLUCOSE SYMPTOM OF SHAKY. TREATMENT WAS NOT SPECIFIED. THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE WITH ANOTHER METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280424 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening