BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3935308 · Received July 15, 2014

    Report

    Report Number
    2939301-2014-17443
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    July 10, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HIS 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 POWER ISSUE BEGAN ¿7 DAYS AGO¿. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN, GLUCORIDE). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED, A WEEK AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿DIZZINESS AND A HEADACHE¿. AT AN UNSPECIFIED DATE/TIME, THE PATIENT STATED HE WENT INTO HIS DOCTOR¿S OFFICE FOR A VISIT. THE PATIENT¿S BLOOD GLUCOSE WAS TESTED AND HE OBTAINED A READING THAT WAS ¿HIGH¿ WITH THE DOCTOR/CLINIC METER. THE PATIENT DID NOT PROVIDE THE ACTUAL READING(S) OBTAINED WITH THE OTHER DEVICE, BUT HIS HEALTH CARE PROFESSIONAL (HCP) TREATED HIM WITH ORAL MEDICATION FOR DIABETES (METFORMIN, GLUCORIDE; UNKNOWN DOSAGES). 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
    413693 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3605021

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R