BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2133981 · Received June 20, 2011

    Report

    Report Number
    2939301-2011-04962
    Event Type
    Injury
    Date Received
    June 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH ULTRA2 METER DOES NOT TURN ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DOES NOT RECALL WHEN THE ALLEGED POWER ISSUE FIRST BEGAN. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (SELF-ADJUSTER). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK FOLLOWING THE ALLEGED POWER ISSUE AND IT IS ALSO NOT KNOWN IF THE PATIENT TESTED THEIR BLOOD GLUCOSE WITH ANOTHER/SECONDARY DEVICE. AT AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF AN INCREASED HEART RATE; IT IS NOT KNOWN HOW LONG THE PATIENT'S SYMPTOM CONTINUED ON FOR AND IT IS NOT KNOWN IF THE PATIENT SUFFERS FROM ANY ADDITIONAL HEALTH CONDITION(S). ACCORDING TO THE CSR'S DOCUMENTATION, ON THE MORNING OF (B)(6) 2011, THE PATIENT ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN AS SELF-TREATMENT. IT IS NOT KNOWN IF PATIENT'S SYMPTOMS IMPROVED AFTER TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER POWERED ON WHEN A TEST STRIP WAS INSERTED; HOWEVER, DID NOT POWER ON MANUALLY. THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS ALLEGEDLY UNABLE TO TEST THEIR BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF HYPERGLYCEMIA 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 INC. 3022571

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R