BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2101154 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04343
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    February 21, 2011
    Report Date
    May 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 HER ONETOUCH ULTRA2 METER WAS DISPLAYING THE BATTERY ICON SYMBOL. 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 PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AN UNSPECIFIED TIME. AS PART OF HER DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON INSULIN. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES REGIMEN AT THE TIME OF THE ALLEGED ISSUE. ON (B)(6) 2011, THE PATIENT CLAIMED SHE PASSED OUT AFTER THE ALLEGED ISSUE BEGAN, BUT IT IS NOT KNOWN IF SHE RECEIVED ANY MEDICAL TREATMENT. IN THE LAST WEEK OF (B)(6) 2011, THE PATIENT STATED SHE HAD A DOCTOR'S OFFICE VISIT. AT THE TIME OF THE DOCTOR'S OFFICE VISIT, THE PATIENT REPORTED BEING TESTED BY THE DOCTOR/CLINIC METER WITH A READING OF "188 OR 108 MG/DL" AND WAS ADMINISTERED 28 UNITS OF LANTUS INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE, THERE WAS NO MISUSE OF THE METER, AND THE METER DID NOT REQUIRE A NEW BATTERY. 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
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R