BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2027969-2015-00668

    MDR report key: 5072407 · Received September 11, 2015

    Report

    Report Number
    2027969-2015-00668
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED DEVICES FROM LOT W59659, WERE TESTED AND NO DEVICE ISSUES WERE OBSERVED. THE RESULTS WERE ALL WITHIN THE 1SD RANGE FOR ALL ANALYTES AND THE CVS WERE WITHIN FINAL RELEASE SPECIFICATIONS. THE CUSTOMER'S COMPLAINT OF DISCREPANT MYO, TNI, AND CKMB WERE NOT OBSERVED. THIS PRODUCT PERFORMED AS EXPECTED. CUSTOMER DID NOT RETURN ANY SAMPLE; CANNOT RULE OUT SAMPLE SPECIFIC INTERFERENCE AS CAUSE OF THE CORRELATION DISCREPANCIES. ALERE TRIAGE DOES NOT MAKE A CLAIM TO CORRELATE TO THE ECI ANALYZER; THE ECI ANALYZER USES A DIFFERENT TNI ASSAY. UNKNOWN WHETHER THE PATIENTS WERE TREATED OR DIAGNOSED WITH HEART CONDITIONS ACCORDING TO TRIAGE RESULTS. BATCH RECORDS FOR LOT W59659, WERE REVIEWED; THIS PRODUCT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING CORRELATION ISSUES BETWEEN TRIAGE CARDIAC PANEL AND THEIR LAB ANALYZER. THE CUSTOMER WAS PERFORMING A REQUIRED CORRELATION STUDY FOR JCAHO. CUSTOMER RAN A 10 SAMPLE CORRELATION; SAMPLE FROM THE EDTA TUBES WAS RUN ON THE TRIAGE AND THEN THE SAME SAMPLE FROM THE SAME TUBE WAS SPUN DOWN TO PLASMA AND RUN ON THEIR LAB INSTRUMENT WITHIN AN HOUR. QCD RUN DAILY ON TRIAGE METER AND PASSING. LIQUID CONTROLS WERE JUST RUN ON THIS LOT OF DEVICES AND PASSED. DATA WAS PROVIDED FOR CREATINE KINASE-MB (CKMB) AND MYOGLOBIN (MYO), NO DATA POINTS PROVIDED FOR TROPONIN I (TNL). CUSTOMER KNOWS THAT THE CUTOFFS AND NORMAL VALUES ARE DIFFERENT FOR EACH METHOD OF TESTING, BUT JCAHO WANTS HER TO COMPARE ACTUAL NUMBERS. THE CORRELATION FOR THE CKMB DATA DID NOT SHOW ANY ISSUES; RESULTS THAT WERE WITHIN THE NORMAL RANGE FOR TRIAGE WERE ALSO WITHIN THE NORMAL RANGE FOR THE LAB ANALYZER. SAMPLES ABOVE THE NORMAL RANGE FOR CKMB ON THE TRIAGE WERE ALSO ABOVE ON THE LAB INSTRUMENT. THERE WERE TWO SETS OF RESULTS FOR THE MYO TESTING THAT GAVE DIFFERENT RESULTS. SEE SECTION B.6 FOR RESULTS AND RANGE INFORMATION. OTHER SETS OF TESTING CORRELATED.

    Patients

    Seq Age Sex Outcome Treatment
    1