BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1243809 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03233
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    LAY USER/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

    THE LAY USER/ PATIENT CONTACTED LFS ALLEGING AN ERROR 5 MESSAGE ON THE ONE TOUCH ULTRA 2 METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT HAD REPORTEDLY BEEN OBTAINING AN ERROR 5 MESSAGE ON HIS ULTRA 2 METER EVERY TIME HE TESTED SINCE 2008. THE PATIENT TOOK HIS SET AMOUNT OF 16 UNITS OF LEVEMIR AFTER ATTEMPTING TO TEST ON THE METER AND ATE BREAKFAST. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS. THE PATIENT CLAIMS THAT HIS INSULIN IS USUALLY A SET AMOUNT; HOWEVER, ONLY IF HIS BLOOD GLUCOSE IS BELOW 7 MMOL/L, THEN HE WOULD ONLY TAKE 6 UNITS OF LEVEMIR. AT 4:00PM, THE PATIENT REPORTEDLY FELT UNWELL, COULD NOT WALK AND WAS ABOUT TO COLLAPSE. THE PATIENT CLAIMS HE USUALLY FEELS THIS WAY IF HIS BLOOD GLUCOSE IS BELOW 4 MMOL/L. THE PATIENT ATTEMPTED TO TEST AND OBTAINED THE ERROR 5 MESSAGE. HE THEN ATE A COCONUT CHOCOLATE AND FELT BETTER 15 MINUTES LATER. THE PATIENT DID NOT SEEK FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. A NORMAL BLOOD GLUCOSE READING IS BETWEEN 11-12 MMOL/L AND THE PATIENT TESTS APPROXIMATELY THREE TIMES A DAY. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION. THE METER IS NOT A NEW PRODUCT (OUT OF BOX). THE ERROR 5 MESSAGE WAS NOT RESOLVED. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT WAS ALLEGEDLY UNABLE TO TEST THE DAY OF THE INCIDENT, TOOK HIS SET AMOUNT OF INSULIN IN THE MORNING; HOWEVER, REPORTEDLY EXHIBITED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA SEVERAL HOURS LATER AND FELT BETTER AFTER SELF-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2872572

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R