BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 4350511 · Received December 22, 2014

    Report

    Report Number
    2939301-2014-35223
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Report Date
    December 15, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR ONE TOUCHULTRA 2 METER WOULD NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ISSUE BEGAN ABOUT A MONTH AND HALF TO TWO MONTHS AGO. THE PATIENT HAD THE SAME ISSUE WITH TWO LOTS OF TEST STRIPS (2790411 AND 3347381). THE PATIENT MANAGES HER DIABETES WITH OTHER DIABETES MEDICATION (¿LYRICA, OMEPRAZOLE, PANCREAZE, TRAMADOL, METOPROLOL, GABAPENTIN¿). THE PATIENT CONFIRMED THAT SHE DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS OF ¿SHAKES¿ ABOUT A WEEK OR TWO AGO. THE PATIENT REPORTED BEING TREATED IN THE EMERGENCY ROOM (ER) AT AN UNSPECIFIED TIME/DATE. IT IS UNKNOWN WHAT TREATMENT WAS RECEIVED. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED, THE BATTERIES DID NOT NEED TO BE REPLACED, THERE WAS NO MISUSE OF THE PRODUCT AND THE ISSUE COULD NOT BE RESOLVED WITH TRAINING. THE CCA ALSO CONFIRMED THE CORRECT STRIPS WERE BEING USED AND THE POWER BUTTON DOES TURN ON THE METER. THE PATIENT WAS ALSO ADVISED NOT TO USE EXPIRED TESTS STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844663 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 2790411

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening