BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3882137 · Received June 18, 2014

    Report

    Report Number
    2939301-2014-14789
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 7, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH ULTRA 2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ¿5 DAYS¿ AGO. THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE; SELF-ADJUSTER) AND DENIED TAKING ANY ACTION IN REGARDS TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT STATED, 2 DAYS AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿SICK, HEAD HURT, AND STAGGERY¿. AT AN UNSPECIFIED DATE/TIME, THE PATIENT STATED SHE WAS TREATED BY A NON-HCP WITH FOOD AND/OR DRINK. THE PATIENT MENTIONED HER BLOOD GLUCOSE WAS TESTED WITH ANOTHER DEVICE AND OBTAINED A ¿LO¿ READING. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE METER AND THERE WAS NO MISUSE OF THE PRODUCT. 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 THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358589 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3612582

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R