BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC

    MDR report key: 126034 · Received October 10, 1997

    Report

    Report Number
    2939301-1997-00071
    Event Type
    Injury
    Date Received
    October 10, 1997
    Date of Event
    September 11, 1997
    Report Date
    September 12, 1997
    Manufacturer
    LIFESCAN INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 PT WAS FEELING ILL WITH NAUSEA, WEAKNESS AND DEEP SLEEP ON 9/11. A BLOOD GLUCOSE TEST PERFORMED ON HER ONE TOUCH BASIC METER AT 5:30/P WAS 45 MG/DL. SHE WAS ADVISED TO CONSUME 8 OZ. ORANGE JUCE. BECAUSE THERE WAS NO IMPROVEMENT IN HER SYMPTOMS, SHE WAS TRANSPORTED TO THE HOSP WHERE A BLOOD GLUCOSE READING OF 654 MG/DL WAS OBTAINED (METHOD UNK). THE PT WAS ADMITTED FOR ELEVATED GLUCOSE AND A BLADDER INFECTION AND TREATED WITH IV FLUIDS AND INSULIN INJECTIONS (OTHER TREATMENT UNK). THE METER IS NOT CLEANED OR MAINTAINED ACCORDING TO MFR'S RECOMMENDATIONS. ALCOHOL IS USED TO CLEAN THE METER OPTICS. THE PRODUCT'S INSTRUCTIONS FOR USE STATE THAT USE OF ALCOHOL AS A CLEANING AGENT CAN DAMAGE THE METER OPTICS. QUALITY CONTROL TESTS DESIGNED TO DETECT POTENTIALLY INACCURATE RESULTS ARE NOT PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R