BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4171825 · Received October 15, 2014

    Report

    Report Number
    2939301-2014-27474
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 7, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 IN THE AFTERNOON. SHE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF ¿157MG/DL¿ WHICH SHE FELT WAS INACCURATELY HIGH AS COMPARED TO HER USUAL READINGS/FEELINGS. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT DOES NOT TAKE ANY MEDICATIONS TO MANAGE HER DIABETES. IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE ALLEGED HIGH READING. THE PATIENT CLAIMED THAT IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿SHAKES, DIZZINESS AND LIGHT HEADEDNESS¿ BUT DESPITE HER SYMPTOMS, SHE DENIED RECEIVING ANY MEDICAL TREATMENT. THE PATIENT REPORTED THAT SHE PURCHASED A NEW METER IMMEDIATELY. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE PATIENT DID NOT HAVE ANY MORE TEST STRIPS AVAILABLE FOR TROUBLESHOOTING. 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 HYPOGLYCEMIA AFTER OBTAINING AN INACCURATE HIGH BLOOD GLUCOSE RESULT ON THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653837 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3642388

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening