BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESCAN INC.

    MDR report key: 111632 · Received August 7, 1997

    Report

    Report Number
    2939301-1997-00056
    Event Type
    Injury
    Date Received
    August 7, 1997
    Date of Event
    July 6, 1997
    Report Date
    August 7, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    CO IS UNABLE TO COMPLETE ITS INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN. THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT. BATCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MFG PROCESS. AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE PATIENT, A 14 Y/O IDDM, WAS NOT FEELING WELL BEGINNING 7/2 OR 7/3, HE WAS "EXTREMELY TIRED AND FATIGUED." ON 7/4, HE HAD NO APPETITE AND WAS SLEEPING THROUGH THE DAY. BY 7/5, HE 'WAS VIOLENTLY THROWING UP." HIS BLOOD GLUCOSE READINGS ON HIS ONE TOUCH BASIC METER THAT EVENING WERE 140-150 MG/DL. HE WAS TRANSPORTED TO THE HOSPITAL AT 1:30/P ON 7/6 WHERE, UPON ARRIVAL, HIS BLOOD GLUCOSE RESULT ON THE HOSPITAL'S ACCUCHECK METER WAS 495 MG/DL. IT WAS REPORTED THAT HIS BS ON HIS BASIC METER AT 1/P WAS 130 MG/DL. HE WAS ADMITTED AND TREATED FOR DEHYDRATION AND ELEVATED GLUCOSE WITH INSULIN AND IV. THE METER, PURCHASED IN JANUARY, 1997, HAS NEVER BEEN CLEANED, NOR HAVE QUALITY CONTROL TESTS DESIGNED TO DETECT POTENTIALLY INACCURATE RESULTS BEEN PERFORMED. IN ADDITION, THE PATIENT WAS IN A DEHYDRATED CONDITION WHILE TESTING ON THE METER. THE PRODUCT'S INSTRUCTIONS FOR USE STATE THAT TESTING WHILE IN A DEHYDRATED CONDITION MAY PRODUCE INACCURATELY LOW TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESCAN INC. BLOOD GLUCOSE METER CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R