BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1911080 · Received November 30, 2010

    Report

    Report Number
    1415939-2010-00545
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO INVESTIGATE THE CUSTOMER CONCERN, THE INVESTIGATION TEAM REVIEWED CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THE CUSTOMER FACILITY. THE REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMS. SPECIFICALLY, THE INVESTIGATION TEAM DID NOT SEE AN INCREASE IN THE NUMBER OF COMPLAINTS RELATED TO FALSE POSITIVE PATIENT RESULTS, OR THE INABILITY TO REPRODUCE RESULTS WHILE USING THE REAGENT LOT NUMBER IN QUESTION. IN ADDITION THE INVESTIGATION TEAM PERFORMED TESTING TO BOTH EVALUATE THE REAGENT AND THE CUSTOMER RETURNED PATIENT SAMPLES. FIRST THE INVESTIGATION TEAM TESTED AN INTERNAL TROPONIN-I PANEL WITH REAGENT LOT 40474UN10. THE PANEL IS MADE FROM HUMAN PLASMA AND CONTAINS A KNOWN CONCENTRATION OF THE TROPONIN-I ANALYTE. THE RESULT WAS WITHIN SPECIFICATION. THIS DEMONSTRATES THAT THE ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION OF TROPONIN-I. TO EVALUATE THE CUSTOMER RETURNED PATIENT SAMPLES THE INVESTIGATION TEAM PERFORMED DILUTION LINEARITY TESTING, INCLUDING SAMPLE TREATMENT WITH A HETEROPHILIC BLOCKING SCANTIBODIES TUBE (HBT). THIS TESTING INDICATES THE FOLLOWING: THE % DIFFERENCES OF THE DILUTIONS FOR EACH PATIENT SPECIMEN DID NOT MET THE EVALUATION CRITERIA OF WITHIN +/- 20%. THIS RESULT IS INDICATIVE OF THE PRESENCE OF AN INTERFERING SUBSTANCE IN THE PATIENT SAMPLE. IN ADDITION HBT TESTING WAS ONLY ABLE TO BE COMPLETED ON ONE SAMPLE (8). THE RESULTS OF THE HBT-TREATED SAMPLE GENERATED A CONCENTRATION DIFFERENT THAN THE UNTREATED SAMPLE (14.973 % ACCEPTABLE RANGE +/- 9.98 %), PER THE HBT PACKAGE INSERT, IF THE SAMPLE CONTAINED HETEROPHILIC ANTIBODIES WE WOULD EXPECT THE RESULT TO BE LOWER THEN THE NEAT RESULT. THIS WAS NOT THE CASE. ALTHOUGH WE WERE UNABLE TO FIND AN EXACT CAUSE OF THE RESULTS THE CUSTOMER OBSERVED, THE ACCURACY TESTING INDICATES THE REAGENTS ARE PERFORMING ACCEPTABLY. THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT DISCUSSES SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW EITHER FALSELY ELEVATED OR DEPRESSED VALUES WHEN TESTED WITH ASSAY KITS THAT EMPLOY MOUSE MONOCLONAL ANTIBODIES. BASED ON THIS INVESTIGATION, IT IS CONCLUDED THAT THE ARCHITECT STAT TROPONIN-I ASSAY IS PERFORMING ACCEPTABLY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULT ON A PATIENT. THE PATIENT PRESENTED WITH CHEST PAIN AND MODERATELY SEVERE LEG ULCERATION. ADDITIONALLY, THE PATIENT HAS CROHN'S DISEASE, PREVIOUS BOWEL RESECTION AND PREVIOUS HISTORY OF CARDIAC PRESENTATION WITH ANGINA. THE FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: NO UNITS OF MEASUREMENT PROVIDED. ARCHITECT STAT TROPONIN-I CUTOFF = 0.03. HETEROPHILE ANTIBODY TEST = NEGATIVE. PEG TREATMENT = INCONCLUSIVE. (B)(6) 2010 AT 16:05. ARCHITECT STAT TROPONIN-I = 0.43, 0.46, POSITIVE (LOT 40474UN10). ARCHITECT STAT TROPONIN-I = 0.007, NEGATIVE (REFERENCE LAB). ROCHE COBAS E411 HIGHLY SENSITIVE TROPONIN-T = 12.9, BORDERLINE THRESHOLD CK = 44, NORMAL REFERENCE RANGE. (B)(6) 2010 AT 19:20. ARCHITECT STAT TROPONIN-I = 0.45, 0.43, POSITIVE (LOT 40474UN10). ARCHITECT STAT TROPONIN-I = 0.008, NEGATIVE (REFERENCE LAB). ROCHE COBAS E411 HIGHLY SENSITIVE TROPONIN-T = 12.4, BORDERLINE THRESHOLD CK = 31, NORMAL REFERENCE RANGE. (B)(6) 2010 AT 12:30. ARCHITECT STAT TROPONIN-I = 0.43, 0.38, POSITIVE (LOT 40474UN10). ARCHITECT STAT TROPONIN-I = 0.005, 0.027, NEGATIVE (REFERENCE LAB). ROCHE COBAS E411 HIGHLY SENSITIVE TROPONIN-T = 19.2, HIGH. (B)(6) 2010 AT 08:05. ARCHITECT STAT TROPONIN-I = 0.44, 0.44, POSITIVE (LOT 40474UN10). ARCHITECT STAT TROPONIN-I = 0.007, 0.029, NEGATIVE (REFERENCE LAB). ROCHE COBAS E411 HIGHLY SENSITIVE TROPONIN-T = 25.9, HIGH. CK = 37, NORMAL REFERENCE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA MMI ABBOTT LABORATORIES 40474UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ARCHITECT I1000SR LIST 1L86-01, SERIAL (B)(4)| ARCHITECT I1000SR LIST 1L86-01, SERIAL (B)(4)