BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2914496 · Received January 14, 2013

    Report

    Report Number
    3008382007-2013-00764
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K002134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER HAD REVERTED TO THE SETUP MODE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012 AT 11:00 AM THE PATIENT NOTED THE REPORTED METER HAD REVERTED TO THE SETUP MODE IMMEDIATELY AFTER A BATTERY REPLACEMENT; HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL. ACCORDING TO THE OWNER'S BOOKLET, THIS METER MAY DISPLAY THE SETUP MODE AFTER THE BATTERY IS REPLACED TO ALLOW THE USER TO UPDATE THE SETTINGS IF NECESSARY. THIRTY MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF "COLD SWEATS." THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS RESOLVED WITH PATIENT EDUCATION AND TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. THERE WAS NO EVIDENCE THE METER WAS NOT FUNCTIONING APPROPRIATELY. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20193 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening