BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3962461 · Received July 29, 2014

    Report

    Report Number
    2939301-2014-18829
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 17, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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) USA ALLEGING THAT THEIR ONE TOUCH ULTRAMINI METER HAD A POWER ISSUE ¿ METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE FIRST OCCURRED AROUND (B)(6) 2014. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (SELF-ADJUSTER) AND DENIED TAKING ANY ACTION IN RESPONSE TO THEIR REGULAR DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE POWER ISSUE. THE PATIENT STATED THAT AT AN UNKNOWN TIME BEFORE THE POWER ISSUE BEGAN THEY DEVELOPED THE SYMPTOM OF ¿SHAKY¿. ON (B)(6) 2014, THE PATIENT REPORTED RECEIVING TREATMENT OF FOOD/DRINK FROM A HCP IN RESPONSE TO THE SYMPTOMS WHICH WERE EXPERIENCED. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THERE WAS NO MISUSE OF THE PRODUCT, THE CORRECT TEST STRIPS WERE BEING USED AND THE ISSUE COULD NOT BE RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. DESPITE THE FACT THAT THE PRODUCT ISSUE DID NOT CAUSE OR CONTRIBUTE TOWARDS THE ONSET OF THE SYMPTOM OF ¿SHAKY¿, THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE DELAY IN TREATMENT THE PATIENT EXPERIENCED. TREATMENT WAS RECEIVED SEVEN DAYS AFTER THE PRODUCT ISSUE ALLEGEDLY BEGAN WHICH SUGGESTS THAT THE PATIENT¿S CONDITION DETERIORATED AS A RESULT OF NOT BEING ABLE TO TEST THEIR BLOOD GLUCOSE; THEREFORE THE ALLEGED POWER ISSUE CONTRIBUTED TOWARDS THE PATIENT RECEIVING HCP TREATMENT FOR A SYMPTOM INDICATIVE OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442115 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3644474

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R