BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3222246 · Received July 12, 2013

    Report

    Report Number
    3008382007-2013-19467
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 21, 2013
    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
    AR, 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) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE POWER ISSUE BEGAN ON (B)(6) 2013. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH A COMBINATION OF LANTUS INSULIN AND ORAL MEDICATION (METFORMIN). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE METER ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿STIFF NECK, HEADACHE, BLURRED VISION, SLURRED SPEECH, AND FEELING TIRED¿ ONE DAY AFTER THE POWER ISSUE STARTED. THE PATIENT CLAIMED HIS BLOOD GLUCOSE REGISTERED ¿OVER 500 MG/DL¿ WHEN HE TESTED ON ANOTHER DEVICE. THE PATIENT STATED HE TREATED HIMSELF WITH 10 TO 15 UNITS OF ADDITIONAL LANTUS INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER DID NOT POWER ON WHEN A TEST STRIP WAS INSERTED OR WHEN A BUTTON WAS PRESSED. THE CCA ALSO NOTED THAT THE SUBJECT METER¿S BATTERY DID NOT NEED TO BE REPLACED PER THE OWNER¿S BOOKLET RECOMMENDATIONS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324347 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3067073

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R