BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3841959 · Received May 31, 2014

    Report

    Report Number
    2939301-2014-12991
    Event Type
    Injury
    Date Received
    May 31, 2014
    Report Date
    May 23, 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
    MI, 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 THE ONETOUCH ULTRAMINI METER HAS A POWER ISSUE (DOES NOT TURN ON). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT TESTS HER BLOOD GLUCOSE READING 5 TIMES PER DAY AND MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN. ON (B)(6) 2014 AT 10 PM, THE SUBJECT METER DID NOT POWER ON. EIGHT HOURS LATER, THE PATIENT REPORTEDLY DEVELOP SYMPTOM OF ¿SWEATING, SHAKING, AND DIZZINESS.¿ AT THE TIME OF CONCERN, THE PATIENT REPORTEDLY MANAGED HER DIABETES WITH MORE FOOD/DRINK. THERE WAS NO REPORT OF ANY REQUIRED HCP MEDICAL INTERVENTION. DURING TROUBLESHOOTING, THE POWER ISSUE WAS NOT RESOLVED. THE SUBJECT METER DID NOT POWER ON WITH THE POWER BUTTON AND INSERTION OF THE TEST STRIP. THERE WAS NO PRODUCT MISUSE. THE LFS PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320602 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3596323

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening