BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3031885 · Received April 3, 2013

    Report

    Report Number
    3008382007-2013-06874
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 15, 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
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT WAS FOUND TO HAVE A LOW/DEAD BATTERY. THE BATTERY WAS REPLACED AND THE METER POWERS ON. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO USUAL DIABETES MANAGEMENT ROUTINE AT THE TIME OF THE ALLEGED ISSUE. LATER THAT EVENING, THE PATIENT CLAIMS SHE HAD "HIGH SUGAR." SYMPTOMS WERE NOT SPECIFIED. THE PATIENT REPORTEDLY INCREASED HER USUAL DOSE OF INSULIN (80 UNITS). NO ADDITIONAL TREATMENT WAS SPECIFIED. THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. 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
    136083 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3292271

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R