BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2549018 · Received April 26, 2012

    Report

    Report Number
    2939301-2012-04190
    Event Type
    Injury
    Date Received
    April 26, 2012
    Report Date
    April 16, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    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 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 7AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "240, 215 AND 223 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH ONGLYZA PILLS (2.5 MG). THE PATIENT CONTINUED TO TAKE HER MEDICATIONS AS USUAL. SEVERAL DAYS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF NERVOUS AND JITTERY. THE PATIENT DID NOT SPECIFY ANY TREATMENT AT THAT TIME. ON THE MORNING OF (B)(6) 2012, THE PATIENT VISITED HER PHYSICIAN'S OFFICE AND WAS ADVISED TO DECREASE HER USUAL DOSE OF ONGLYZA PILLS (2 MG). THAT SAME MORNING, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "144 MG/DL" WITH THE PHYSICIAN/ CLINIC METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. A CONTROL SOLUTION TEST WAS PERFORMED WHICH FELL WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3145192

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening