BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1739185 · Received June 28, 2010

    Report

    Report Number
    2939301-2010-05117
    Event Type
    Injury
    Date Received
    June 28, 2010
    Report Date
    June 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA METER DOES NOT TURN ON. THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT ON (B)(6) 2010 TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. THE PATIENT MANAGES HER DIABETES WITH METFORMIN ORAL MEDICATION AND TESTS HER BLOOD GLUCOSE TWICE PER DAY. AFTER THE POWER ISSUE BEGAN IN (B)(6) 2009, THE PATIENT CLAIMED THAT SHE WAS UNABLE TO OBTAIN HER BLOOD GLUCOSE READINGS FOR 8 MONTHS. ON SEVERAL DIFFERENT OCCASIONS, THE PATIENT REPORTEDLY WENT TO THE HEALTH CLINIC AND OBTAINED "REALLY HIGH READINGS." DURING THE ALLEGED INCIDENTS, THE PATIENT FELT WEAK AND ALLEGEDLY RECEIVED INSULIN TREATMENT FOR A BLOOD GLUCOSE READINGS IN THE "400 MG/DL." ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED. THE CUSTOMER CARE ADVOCATE CONCLUDED THAT THE BATTERY DID NOT NEED TO BE REPLACED. IN ADDITION, THERE WAS NO PRODUCT MISUSE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE RECEIVED MEDICAL INTERVENTION SUGGESTIVE OF HYPERGLYCEMIA AFTER THE PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2937843

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R