BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH FASTTAKE

    MDR report key: 661721 · Received December 29, 2005

    Report

    Report Number
    2939301-2005-05984
    Event Type
    Malfunction
    Date Received
    December 29, 2005
    Date of Event
    December 27, 2005
    Report Date
    December 28, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A LAY REPORTER CONTACTED LIFESCAN (LFS) IN 2005 ALLEGING THAT HER MOTHER'S METER HAD BEEN DISPLAYING ERRATIC READINGS. MEDICAL AFAFAIRS SPEC. (MAS) SPOKE TO THE FAMILY MEMBER ONE DAY LATER AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION: ONE DAY EARLIER IN THE MORNING, THE FAMILY MEMBER TESTED THE MOTHER'S BLOOD GLUCOSE READING AND RECEIVED 190 MG/DL AND RETESTED DUE TO THE HIGH READING AND RECEIVED A 111 MG/DL. THE TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE LAY USER/PT DID NOT EXPERIENCE ANY SYMPTOMS AT THE TIME OF TESTING AND TOOK HER SET AMOUNT OF LANTUS. DUE TO THE ERRATIC READINGS, THE FAMILY MEMBER CONTACTED THE PT'S PHYSICIAN. THE PT WAS SEEN AT THE PHYSICIAN'S OFFICE WITHIN AN HOUR. SHE WAS TESTED ON THE PHYSICIAN'S METER; HOWEVER, FAMILY MEMBER DOES NOT RECALL READING. THE PHYSICIAN CHANGED PT'S MEDICATION FROM LANTUS 1X A DAY TO HUMALOG 2X A DAY. THE DIABETES MEDICATION WAS CHANGED DUE TO HER CHEMOTHERAPY. THE PHYSICIAN ALSO REQUESTED TO HAVE THE PT TEST FROM ONCE A DAY TO THREE TIMES A DAY. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE PT DID NOT HAVE CONTROL SOLUTION TO CHECK THE TEST STRIP. CUSTOMER CARE AGENT (CCA) SENT THE PT A REPLACEMENT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH FASTTAKE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2589416

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR