BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3141134 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14066
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 9, 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
    PA, 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) USA, ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READING OF 400 MG/DL COMPARED TO NORMAL READING/FEELING. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT¿S DIABETES IS NOT MANAGED WITH ANY DIABETES MEDICATION. THE PATIENT REPORTEDLY RECEIVED THE REPORTED ELEVATED READINGS ON (B)(6) 2013 AT 5 PM. AT AROUND 5:30 PM, THE PATIENT TOOK 5 UNITS OF HUMALOG INSULIN. IT WAS NOTED THAT THE PATIENT WAS TESTED ON AN EMERGENCY MEDICAL SERVICE METER AT 22 MG/DL. THE PATIENT DID NOT HAVE ANY SYMPTOMS AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THERE WAS NO TEST STRIP AT THE TIME TO PERFORM A QUALITY TEST. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD READING OF 22 MG/DL AFTER HE TOOK INSULIN BASED ON THE ALLEGED LFS METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243446 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening