BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 5222240 · Received November 13, 2015

    Report

    Report Number
    2939301-2015-48753
    Event Type
    Injury
    Date Received
    November 13, 2015
    Report Date
    November 4, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DEVICE EVALUATION: THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. 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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA METER HAD A POWER ISSUE - METER WAS REVERTING TO SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS UNABLE TO BE CONTACTED, DESPITE NUMEROUS ATTEMPTS, IN ORDER TO GAIN ADDITIONAL INFORMATION. THE PATIENT WAS UNABLE TO STATE WHEN THE ALLEGED POWER ISSUE STARTED, NOR COULD THEY PROVIDE ANY INFORMATION REGARDING THEIR NORMAL DIABETES MANAGEMENT REGIMEN. THE CCA DID RECORD, HOWEVER, THAT AN UNSPECIFIED PERIOD OF TIME AFTER THE ALLEGED POWER ISSUE STARTED, THE PATIENT DEVELOPED THE SYMPTOMS OF "SHAKINESS AND INCREASED APPETITE". IT IS NOT KNOWN WHETHER THE PATIENT REQUIRED ANY FORM OF TREATMENT AS A RESULT OF THESE SYMPTOMS, AND IT IS ALSO NOT KNOWN WHETHER THE PATIENT WAS ABLE TO TEST THEIR BLOOD GLUCOSE ON ANY OTHER DEVICE AT THIS TIME. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THERE WAS NO MISUSE OF THE PRODUCT AND THE ISSUE COULD NOT BE RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER BEING UNABLE TO TEST THEIR BLOOD GLUCOSE ON THE SUBJECT METER. THE ALLEGED METER ISSUE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752499 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3842941

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening