BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1030146 · Received April 15, 2008

    Report

    Report Number
    2939301-2008-00572
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 30, 2008
    Report Date
    March 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WOULD NOT TURN ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT BY TELEPHONE. THE MAS MAILED A LETTER TO THE PT AS AN ATTEMPT TO OBTAIN/VERIFY INFO. THE PT TESTS HER BLOOD GLUCOSE 3 TIMES A DAY. SHE MANAGES HER DIABETES WITH PILLS, DIET, AND EXERCISE. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE SAME DAY, AT 12 PM. THE PT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. AT AN UNSPECIFIED TIME AFTER THE REPORTED ISSUE BEGAN, THE PT DEVELOPED SYMPTOMS OF SHAKINESS. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHAT TIME THE PT DEVELOPED THE SYMPTOMS, WHAT ACTIONS THE PT TOOK BEFORE, DURING, AND AFTER THE SYMPTOMS DEVELOPED, AND WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE ALLEGED METER ISSUE. THE REPORTED METER ISSUE WAS RESOLVED WITH TRAINING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED TO HAVE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2771728

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening