BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1182103 · Received October 2, 2008

    Report

    Report Number
    1628664-2008-00226
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 6, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS, NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT TEXT INDICATES DISCREPANT VANCOMYCIN (VANCO) AND CKMB RESULTS WERE GENERATED ON AXSYM SN# (B)(4) ON (B)(6) 2008. THIS WAS THE SECOND OCCURRENCE OF DISCREPANT RESULTS GENERATED ON AXSYM SN# (B)(4), WITH THE FIRST OCCURRING ON (B)(6) 2008 AND WAS DOCUMENTED IN COMPLAINT (B)(4). COMPLAINT (B)(4) WAS CLOSED AS A NONREPORTABLE COMPLAINT WITH THE MOST PROBABLE ROOT CAUSE IDENTIFIED AS FIBRIN IN THE PATIENT SAMPLE. IN COMPLAINT (B)(4), THE INITIAL VANCO RESULT WAS 0.85 AND 19.96 AFTER REPEAT. THE PATIENT SAMPLE WAS DRAWN IN A SERUM TUBE AND ALL QC WAS WITHIN RANGE. THE ASSAY WAS LAST CALIBRATED ON (B)(6) 2008 AND THE CONTROL IN USE WAS BIORAD LOT 40710. ON (B)(6) 2008, A DIFFERENT PATIENT SAMPLE HAD AN INITIAL CKMB RESULT OF 7.5 WHICH IS CONSIDERED A LAB PANIC VALUE SO THE SAMPLE WAS REPEATED. THE REPEATED RESULTS WERE 1.0. ALL ABBOTT CKMB QC WAS WITHIN RANGE. THE PATIENT SAMPLE WAS COLLECTED IN LITHIUM HEPARIN TUBE AND ALL OTHER RESULTS WERE AS EXPECTED. THE CKMB WAS LAST CALIBRATED ON (B)(6) 2008. THE PROCESSING PROBE WAS ON THE ANALYZER SINCE (B)(6) 2008 AND THE SAMPLE PROBE WAS LAST CHANGED (B)(6) 2008. MESSAGE HISTORY REVIEW DOES NOT REVEAL ANY PROBE CRASH ERRORS. MEIA AND FPIA VERIFICATIONS WERE PERFORMED (B)(6) 2008 AND NO UPDATES WERE REQUIRED. THE FPIA LAMP CURRENT = 5.90 AND THE MEIA LAMP CURRENT = 4.5. THE CUSTOMER DECLINED ANY FURTHER TROUBLESHOOTING AND REQUESTED FIELD SERVICE. THE FIELD SERVICE REP VISITED THE ACCOUNT AND FOUND THE SAMPLE PROBE OUT OF ALIGNMENT. BOTH PROBES WERE CALIBRATED, THE FLUIDICS CHECK WAS PERFORMED AND THE ANALYZER WAS FOUND TO BE PERFORMING TO SPECIFICATION. A REVIEW OF SERVICE HISTORY FOR SERIAL NUMBER # (B)(4) INDICATES THERE WERE NO ADDITIONAL DISCREPANT RESULT COMPLAINTS GENERATED FOLLOWING FIELD SERVICE INTERVENTION. THE AXSYM SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION CONCERNING ERRATIC/ DISCREPANT RESULTS. THE AXSYM VANCOMYCIN PACKAGE INSERT (LN# 34-3919/R6) AND THE CK-MB PACKAGE INSERT (LN# 34-3508/R8), PROVIDES LITERATURE IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. FAILURE TO FOLLOW PACKAGE INSERT INSTRUCTION MAY CAUSE ERRONEOUS RESULTS. REVIEW OF (B)(6) 2008 COMPLAINTS AND METRICS IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER INVESTIGATION. THE MOST PROBABLE ROOT CAUSE FOR THE ERRATIC RESULTS IS THE SAMPLE PROBE OUT OF ALIGNMENT, HOWEVER THE ACTUAL ROOT CAUSE CAN NOT BE DETERMINED WITH THE AVAILABLE INFORMATION AND THE MULTIPLE CORRECTIVE ACTIONS PERFORMED. CALIBRATING BOTH PROBES AND PERFORMING A FLUIDICS CHECK RETURNED THE INSTRUMENT TO SPECIFICATION. A DEFICIENCY OF THE AXSYM SYSTEM WAS NOT IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THEY ARE GENERATING DISCREPANT RESULTS ON THE AXSYM ANALYZER WITH VANCOMYCIN AND CKMB ASSAYS. PATIENT 1 GENERATED AN AXSYM VANCOMYCIN = 0.85 (NO UNITS OF MEASUREMENT WERE PROVIDED). THE ACCOUNT QUESTIONED THE RESULT AND RERAN WITH AN AXSYM VANCOMYCIN = 19.69 (NO UNITS OF MEASUREMENT WERE PROVIDED). ALL QUALITY CONTROL WAS IN RANGE. SERVICE DISCOVERED THE AXSYM SAMPLE PROBE WAS OUT OF ALIGNMENT. SERVICE CORRECTED THE SAMPLE PROBE ALIGNMENT AND PERFORMED A PROBE CALIBRATION ON BOTH PROBES AND PERFORMED A FLUIDICS CHECK. THE QUESTIONED AXSYM VANCOMYCIN RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM VANCOMYCIN LIST 5B75-20, LOT 60512Q103| AXSYM VANCOMYCIN LIST 5B75-20, LOT 60512Q103