BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3141484 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14158
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HER ONETOUCH ULTRA2 WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATES (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT AN UNKNOWN TIME IN THE EVENING. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH A COMBINATION OF LANTUS AND HUMALOG INSULIN AND METFORMIN AND GLYBURIDE PILLS (UNKNOWN DOSE) AND REPORTED THAT IN RESPONSE TO THE ALLEGED ISSUE SHE SKIPPED TAKING HER MEDICATIONS ON THAT SAME EVENING. SHE CLAIMED THAT AT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿SHAKING, SWEATS AND DIZZINESS.¿ THE PATIENT DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER¿S BATTERIES WERE NOT DUE FOR REPLACEMENT. THE METER DID NOT POWER ON WITH THE POWER BUTTON, AND THE PATIENT DID NOT HAVE ANY TEST STRIPS TO TROUBLESHOOT WITH. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND 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
    244914 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3375968

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening