BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAST BLOOD GLUCOSE SYSTEM

    MDR report key: 287742 · Received July 27, 2000

    Report

    Report Number
    2954106-2000-00001
    Event Type
    Injury
    Date Received
    July 27, 2000
    Date of Event
    June 30, 2000
    Manufacturer
    AMIRA MEDICAL
    Product Code
    JJQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT PURCHASED A NEW BLOOD GLUCOSE SYSTEM AT THE LOCAL COSTCO PHARMACY. AFTER RETURNING HOME PT COMPLETED ONE BLOOD TEST. PT DESIRED MORE INFO ON THE RESULT DISPLAYED SO PT CONTACTED AMIRA MEDICAL CUSTOMER SERVICE. IN RESPONDING TO THE PT'S QUESTIONS THE REP DISCOVERED THAT THE PT'S METER HAD A LANCET IN IT PRIOR TO THE PT'S USE. THE REP ASKED IF THE RETAIL BOX TAMPER RESISTANT SEALS WERE INTACT PRIOR TO USE. THE PT INDICATED THE SEALS HAD BEEN BROKEN. IN ADDITION THERE WAS OTHER EVIDENCE THAT THE METER HAD PREVIOUSLY BEEN USED. THE LANCET BAG SEAL HAD BEEN REMOVED, THE CALIBRATION CHIP WAS INSTALLED IN THE METER AND THERE WERE TWO ADD'L VALUES IN THE METER MEMORY WHILE THE PT HAD TESTED ONLY ONCE. THE PT WAS INFORMED THAT A SUPERVISOR WOULD BE CALLING BACK FROM AMIRA MEDICAL. ON THE SAME DATE THE SUPERVISOR CONTACTED THE PT. AT THIS TIME THE PT REALIZED THE METER HAD BEEN PREVIOUSLY USED. PT HAD CONTACTED PHYSICIAN AND WAS SCHEDULED FOR AN HIV AND HEPATITIS SCREENING IN 6 WEEKS (08/06/2000). PT ALSO INFORMED COSTCO OF THE INCIDENT. AN AMIRA SUPERVISOR CONTACTED THE PHARMACIST AT COSTCO PHARMACY. THE PHARMACY WAS NOTIFIED THAT 2 TEST RESULTS IN THE MEMORY WERE NOT THE PT'S RESULTS, INDICATING PRIOR USE. COSTCO HAS INFORMED AMIRA THAT THEY HAVE SUBMITTED AN MDR ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAST BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE MONITOR JJQ AMIRA MEDICAL 00549 00542

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other