BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2872110 · Received December 13, 2012

    Report

    Report Number
    3008382007-2012-08079
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 19, 2012
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DOES NOT POWER ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN (B)(6) 2012 (DATE/TIME NOT KNOWN). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN AND AFTER THE ALLEGED POWER ISSUE OCCURRED, THE PATIENT REPORTEDLY CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF SHAKING AT AN UNKNOWN TIME LATER. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE SUBJECT METER'S BATTERIES WERE NOT REPLACED PER OWNER'S BOOKLET RECOMMENDATION, THE PATIENT WAS USING THE CORRECT TEST STRIPS AT THE TIME THE ALLEGED ISSUE OCCURRED, AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3264787

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening