BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3141624 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14241
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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/REPORTER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRA 2 METER HAS A POWER ISSUE (BATTERY INDICATOR). THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT¿S DIABETES IS MANAGED WITH ORAL MEDICATION. ACCORDING TO THE REPORTER, THE POWER ISSUE BEGAN A MONTH PRIOR TO CONTACTING LFS. REPORTEDLY, THE PATIENT WAS UNABLE TO CHECK HER BLOOD GLUCOSE AFTER THE ISSUE BEGAN AND HER VISION BECAME BLURRY. THE PATIENT STATED THAT SHE INCREASE DIABETES MEDICATION AT THE TIME OF CONCERN. THERE WAS NO REPORT OF ANY REQUIRED HCP MEDICATION INTERVENTION DUE TO THE REPORTED ISSUE. TROUBLESHOOTING INDICATED THE BATTERY NEEDED TO BE REPLACED BUT THE PATIENT DID NOT HAVE A BATTERY AT THE TIME TO RESOLVE THE ISSUE. THERE WAS NO PRODUCT MISUSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCE SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA DUE TO A POWER ISSUE ASSOCIATED WITH POSSIBLE USE ERROR (BATTERY WAS NOT REPLACED PER THE INSTRUCTION FOR USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243755 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening