BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 3200898 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18841
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 9AM. SHE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF "248MG/DL" WHICH SHE FELT WAS INACCURATELY HIGH AS COMPARED TO HER FEELINGS/NORMAL READINGS. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS AS NORMAL. THE PATIENT REPORTED THAT SHE IS NOT TAKING ANY MEDICATION TO MANAGE HER DIABETES AND CONTINUED WITH HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT A FEW HOURS AFTER THE ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF "FEELING SHAKY." SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS PERFORMED AND IT FELL WITHIN THE RANGE SPECIFIED ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303377 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3434176

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening