BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 95336 · Received May 30, 1997

    Report

    Report Number
    1628664-1997-00053
    Event Type
    Other
    Date Received
    May 30, 1997
    Date of Event
    May 1, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION: THE ACCOUNT STATED THAT THE PT SAMPLE HAD CLOTTING PROBLEMS AND REQUIRED 30 MINUTES TO CLOT, PRIOR TO SPINNING. AXSYM SYSTEMS OPERATIONS MANUAL (FEB. 1996), SECTION 10, LISTS "FIBRIN, RED BLOOD CELLS OR PARTICULATE MATTER PRESENT IN SAMPLE" AS PROBABLE CAUSES FOR RESULTS BEING ERRATIC, DISCREPANT, AND/OR EXPERIENCING IMPRECISION (PG. 10-270). ADDITIONALLY, LABELING STATES IN THE PACKAGE INSERT, UNDER LIMITATIONS OF THE PROCEDURE, THAT RESULTS SHOULD BE USED IN CONJUNCTION WITH CLINICAL OBSERVATIONS OF THE PT. AS AN ADD'L INVESTIGATION, 12 MONTHS OF DATA FOR TOTAL COMPLAINTS AGAINST THE AXSYM ANALYZER WAS REVIEWED. NO ADVERSE TRENDS WERE FOUND REQUIRING FURTHER INVESTIGATIONS. NO CORRECTIVE ACTION IS REQUIRED. ADEQUATE LABELING EXISTS TO MINIMIZE ANY ASSOCIATED RISK TO PT RESULTS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 05/01/1997 THE ACCOUNT REPORTED ERRATIC PHENYTOIN AND PHENOBARBITAL RESULTS, WHICH WERE RUN ON THE AXSYM ANALYZER. THE PATIENT WAS TAKEN TO THE HOSPITAL ER ON 04/30/1997 FOR CONVULVSION WITH POSSIBLE BLEEDING IN THE BRAIN, AFTER HAVING BEEN SHAKEN BY HIS MOTHER, A DRUG ADDICT. THE INFANT WAS DOSED IN THE ER AND THE FOLLOWING RESULTS WERE RECEIVED: 05/01/1997, 04:50 AM, PHENYTOIN=9.69, PHENOBARBITAL=60.62; 05/01/1997, 09:00 AM, PHENYTOIN=14.69, PHENOBARBITAL NOT TESTED; 05/01/1997, 15:40 PM, PHENYTOIN=2.57, PHENOBARBITAL=7.78. THE INFANT WAS DOSED BASED ON THE 05/01/1997, 15:40 PM, RESULTS. THE FOLLOWING RESULTS WERE OBTAINED ON 05/02/1997, 04:00 AM, PHENYTOIN=36.5, PHENOBARBITAL=74.89, 05/02/1997, 08:00 AM, PHENYTOIN=32, PHENOBARBITAL=40.2. AFTER RECEIVING THESE RESULTS, THE DOCTOR QUESTIONED THE RESULTS FROM 05/01/1997 AT 15:30 PM. THE SAMPLE WAS RETESTED AND GAVE PHENYTOIN=27, PHENOBARBITAL=58. ACCORDING TO THE ACCOUNT, THE PT'S SAMPLES TOOK A LONG TIME TO CLOT AND SAT FOR 30 MINUTES BEFORE SPINNING, HOWEVER SAMPLE APPEARANCE WAS NORMAL AFTER SPINNING. AN ALERT OR FLAG WAS NOT GIVEN WITH THE ERRATIC RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MFG., INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO AXSYM PHENTOIN REAGENT, LIST#7A67-20,LOT#25437M401| AXSYM PHENOBARBITAL REAGENT,#7A70-20,LOT#25438M400