BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC

    MDR report key: 146806 · Received January 29, 1998

    Report

    Report Number
    2939301-1998-00001
    Event Type
    Injury
    Date Received
    January 29, 1998
    Date of Event
    December 1, 1997
    Report Date
    December 30, 1997
    Manufacturer
    LIFESCAN INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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 REPORTED THAT SHE HAD BEEN HOSPITALIZED FOR 29 DAYS IN A DIABETIC COMA. IT WAS REPORTED THAT HER ONE TOUCH BASIC METER, USING QUICK CHECK ONE TEST STRIPS LOT # 161425 (B) (EXP. 12/1997), READ 75 MG/DL THE MORNING OF HER HOSPITALIZATION. A BLOOD GLUCOSE RESULT OBTAINED UPON ARRIVAL (METHOD UNKNOWN) WAS 724 MG/DL. NO OTHER INFO IS AVAILABLE AS THE PT'S TELEPHONE HAD BEEN DISCONNECTED AND THERE WAS NO RESPONSE TO A LETTER SENT TO HER ON 12/30. THE METER HAS NOT BEEN RETURNED FOR EVALUATION.

    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 * Hospitalization| R QUICK CHECK ONE TEST STIPS LOT # 161428 (B).