BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1133256 · Received August 21, 2008

    Report

    Report Number
    2939301-2008-01910
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING MISSING SEGMENTS ON THE DISPLAY. IN THE SAME MONTH, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO CLARIFY INFORMATION OBTAINED FROM THE INITIAL CALL. THE PATIENT TESTS HER BLOOD GLUCOSE 4 TIMES PER DAY AND TAKES 500 MG OF METFORMIN 3 TIMES PER DAY. ELEVEN DAYS PRIOR, THE PATIENT INDICATED THAT SHE NOTICED THAT THE SUBJECT METER WAS MISSING SEGMENTS ON THE DISPLAY AND REPLACED THE BATTERY. THE PATIENT STATED THAT REPLACING THE BATTERY DID NOT RESOLVE THE ISSUE. AS A RESULT OF THE MISSING SEGMENTS, THE PATIENT REPORTEDLY STOPPED USING THE SUBJECT METER. THE PATIENT HAD A BACKUP METER (BAYER) BUT INDICATED THAT SHE ONLY HAD 1 OR 2 TEST STRIPS. ALLEGEDLY, THE PATIENT DID NOT TEST HER BLOOD GLUCOSE THE WHOLE DAY. DURING THE EVENING TIME, THE PATIENT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "SWEATY AND FORGETFUL." WHEN THE PATIENT WAS TESTED ON A BACKUP METER, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "55 AND 72 MG/DL." THE PATIENT PROMPTLY TOOK SUGARS AND THE SYMPTOMS ABATED WITHIN 15 MINUTES. THE PT FELT THAT IF SHE HAD BEEN ABLE TO TEST HER BLOOD GLUCOSE ON THE DAY OF CONCERN, SHE COULD HAVE PREVENTED THE AFOREMENTIONED SYMPTOMS. THE PATIENT'S DIABETES MEDICATION HAS NOT BEEN CHANGED IMMEDIATELY BEFORE OR AFTER THE DAY OF THE INCIDENT. DURING TROUBLESHOOTING, THE REPORTED ISSUE (MISSING SEGMENTS) COULD NOT BE RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2798261

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R