BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3033223 · Received April 3, 2013

    Report

    Report Number
    3008382007-2013-06885
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 12, 2013
    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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER WAS NOT POWERING ON WHEN SHE TRIED TO TEST. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED THE WEEK PRIOR TO CONTACTING LFS IN THE AFTERNOON. THE PATIENT REPORTED USING "SHOT OTHER THAN INSULIN" TO MANAGE HIS DIABETES. THE PATIENT WITHIN 1-2 WEEKS OF THE ALLEGED ISSUE OCCURRING, HE HAD MORE TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED 2 WEEKS LATER HE DEVELOPED SYMPTOMS OF "HIGH BLOOD GLUCOSE". IT IS UNCLEAR WHAT SPECIFIC SYMPTOMS THE PATIENT WAS EXPERIENCING. THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION IN RESPONSE TO THE REPORTED SYMPTOMS. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE CCA NOTED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED, AND THERE WAS NO MISUSE OF THE PRODUCT. WHEN THE PATIENT PRESSED THE POWER BUTTON, THE METER DID NOT TURN ON. THE PATIENT DID NOT HAVE THE CORRECT TEST STRIPS AT THE TIME OF THE CALL. THE CCA DETERMINED THE METER BATTERY DID NOT NEED TO BE REPLACED. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136495 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 5A2A25

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening