BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT CK-MB

    MDR report key: 2510321 · Received March 30, 2012

    Report

    Report Number
    1415939-2012-00091
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 9, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JLB
    PMA / PMN Number
    K041596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS CONDUCTED TO INVESTIGATE THIS ISSUE. CUSTOMER COMPLAINTS RECEIVED TO-DATE WERE REVIEWED TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THIS FACILITY. THE REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 44152UN10. TESTING USING REAGENT LOT 44152UN10 WAS PERFORMED IN ORDER TO DETERMINE IF THE ASSAY COULD ACCURATELY READ VARYING CONCENTRATIONS OF CK-MB. ONE ARCHITECT INSTRUMENT WAS CALIBRATED AND CONTROLS WERE RUN TO VALIDATE THE RUN. SIX REPLICATES OF TWO PANELS WITH KNOWN CONCENTRATIONS OF CK-MB WERE TESTED AND THE RESULTS WERE EVALUATED AGAINST THEIR SPECIFICATIONS. THE CONCENTRATIONS FOR EACH OF THE PANELS WERE WITHIN SPECIFICATION, WHICH INDICATED THAT THE ASSAY IS CAPABLE OF ACCURATELY READING VARYING CONCENTRATIONS OF CK-MB. BASED ON THIS INVESTIGATION, IT WAS DETERMINED THAT THE ARCHITECT STAT CK-MB ASSAY IS PERFORMING ACCEPTABLY. NO DEFICIENCY WAS IDENTIFIED RELATED TO THE ALLEGED MALFUNCTION REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SEVERAL PATIENT SAMPLES GENERATED DISCREPANT RESULTS FOR THE ARCHITECT CK-MB ASSAY. THE RESULTS WERE DISCREPANT ON THE ARCHITECT VERSES TWO OTHER (NON-ABBOTT) METHODS (VIDAS AND ADVIA). DATA FROM (B)(4) PATIENTS WAS PROVIDED, (B)(4) OF WHICH GENERATED CLINICALLY DISCREPANT RESULTS BETWEEN THE ARCHITECT AND THE OTHER TWO METHODS. THE CUT-OFF POINT THE CUSTOMER IS USING FOR THE ARCHITECT IS 6.6 NG/ML, FOR VIDAS 5.1 AND FOR ADVIA IS 5.0 NG/ML. ONE PATIENT SAMPLE GENERATED A NEGATIVE RESULT OF 3.0 NG/ML ON THE ARCHITECT COMPARED TO A POSITIVE RESULT OF 6.34 (VIDAS) AND A POSITIVE RESULT OF 5.95 NG/ML (ADVIA). SUSPECT RESULTS WERE NOT REPORTED OUT AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT CK-MB JLB ABBOTT LABORATORIES 44152UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER 01L86-01 SN (B)(4)| ARCHITECT ANALYZER 01L86-01 SN (B)(4)