BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4220194 · Received November 3, 2014

    Report

    Report Number
    2939301-2014-29434
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 25, 2014
    Report Date
    October 25, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HIS ONE TOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO RESULTS OBTAINED ON ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS NOT AVAILABLE TO ANSWER FOLLOW-UP QUESTIONS FROM MEDICAL SURVEILLANCE (MS). THE PATIENT CLAIMED THAT ON THE MORNING OF (B)(6) 2014, HE OBTAINED RESULTS OF ¿516MG/DL AND 520MG/DL¿ ON THE SUBJECT METER, WHICH HE FELT WAS INACCURATELY HIGH IN COMPARISON TO READINGS OF ¿47MG/DL¿ OBTAINED ON AN UNKNOWN DEVICE. THE PATIENT STATED THAT THE TWO TESTS WERE PERFORMED WITHIN 30 MINUTES. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT DETAILED THAT HE CURRENTLY MANAGES HIS DIABETES BY SELF-ADJUSTING HIS INSULIN DOSES. THE PATIENT STATED THAT ¿40 MINUTES¿ AFTER THE ALLEGED INACCURACY HE ¿PASSED OUT¿. THE PATIENT CLAIMED THAT HE CONSUMED ¿THREE GLUCOSE TABLETS¿ AT 11:00AM ON (B)(6) 2014. DURING TROUBLESHOOTING, THE CCA NOTED THAT METER HAD BEEN SET TO THE CORRECT UNIT OF MEASURE AND THAT THE TEST STRIPS WERE IN GOOD CONDITION AND HAD NOT EXPIRED. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST, BUT THE PATIENT WAS UNABLE TO CONFIRM IF THE RESULTS WERE IN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701018 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3681780

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R