BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2110615 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04491
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. 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

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH ULTRAMINI METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON THE EARLY MORNING OF (B)(6) 2011. THE PATIENT OBTAINED A RESULT OF 523 MG/DL AND 79 MG/DL WITHIN 20 MINUTES FROM ONE ANOTHER. DUE TO THE ALLEGED ISSUE THE PATIENT INCREASED THEIR DOSAGE OF MEDICATION (5 UNITS OF HUMALOG). A FEW MINUTES AFTER TESTING THE PATIENT BECAME SHAKY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TESTS TRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE CONTROL SOLUTION WAS NOT PROVIDED. METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERRATIC RESULTS, THE PATIENT INCREASED THEIR DOSAGE OF MEDICATION AND SHORTLY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3122268

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening