BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3864969 · Received June 11, 2014

    Report

    Report Number
    2939301-2014-14067
    Event Type
    Injury
    Date Received
    June 11, 2014
    Report Date
    June 6, 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
    FL, 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)(46) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THE ONETOUCH ULTRA2 METER HAS A MISSING SEGMENT ON THE DISPLAY. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND THE FOLLOW-UP INFORMATION OBTAINED ON (B)(6) 2014. ACCORDING TO THE PATIENT, HE AWOKE ON (B)(6) 2014, AT 7 AM, WITH SYMPTOMS OF FEELING COLD SWEAT AND WEAK. HE ATTEMPTED TO GET A READING ON THE SUBJECT METER BUT COULD NOT READ THE DISPLAY. AT THE TIME OF CONCERN, THE PATIENT DID NOT TAKE ANY TREATMENT UNTIL 30 MINUTES LATER WHEN HE TESTED ON ANOTHER METER AT ¿38 MG/DL.¿ AT THAT TIME, THE PATIENT WAS ABLE TO ADMINISTER SELF TREATMENT WITH FOOD AND DRINK. HE REPORTEDLY FELT BETTER SOON AFTER. THE DISPLAY ISSUE WAS NOT RESOLVED WITH TRAINING. THERE WAS NO EVIDENCE OF A PRODUCT MISUSE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT COULD NOT ADMINISTER SELF TREATMENT FOR 30 MINUTES AFTER THE ONSET OF THE REPORTED DISPLAY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344915 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R