BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 14748915 · Received June 20, 2022

    Report

    Report Number
    3005094123-2022-00131
    Event Type
    Injury
    Date Received
    June 20, 2022
    Date of Event
    May 24, 2022
    Report Date
    July 25, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PHONE COMPLETE ENTRY = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE PATIENT, WHO UNDERWENT AN UNNECESSARY CARDIAC CATHETERIZATION BECAUSE OF THE ELEVATED RESULTS, INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED KIT OF LOT 37587UD00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT THIS ADVERSE EVENT REPRESENTS A CORRECT USE; HOWEVER, PER THE LIMITATIONS OF THE PROCEDURE, ANY CONDITION RESULTING IN MYOCARDIAL INJURY CAN POTENTIALLY INCREASE CARDIAC TROPONIN I LEVELS. FOR MI DIAGNOSTIC PURPOSES, THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER INFORMATION SUCH AS ECG, CLINICAL OBSERVATIONS, AND SYMPTOMS, ETC. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I STAT HIGH SENSITIVE TROPONIN-I, LOT NUMBER 37587UD00, WAS IDENTIFIED. SECTION G1 - MFG SITE EMAIL INFORMATION UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE PATIENT OVER FIVE DAYS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S CUT OFF IS 26 PG/ML): SAMPLE ID (B)(6) RESULT, ON 24MAY, WAS 114 PG/ML, REPEAT WAS 109.73 PG/ML. A MANUAL 1:11 DILUTION GAVE RESULTS OF 160.7 AND 147.31 PG/ML. AN AUTOMATIC DILUTION OF 1:10 GAVE RESULTS OF 138.76 AND 135.03 PG/ML. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: GOT WAS 63.0 U/L, GPT WAS 66.2 U/L, GGT WAS 163 U/L, CPK WAS 934 U/L, CK-MB WAS 34.8 U/L, CK-MB/TOTAL CK AWS 3.73%. SAMPLE ID (B)(6) RESULT, ON 25MAY, WAS 120 PG/ML. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: CPK WAS 947 U/L, CK-MB WAS 31.9 U/L, CK-MB/TOTAL CK WAS 3.37%. SAMPLE ID (B)(6) RESULT, ON 26MAY, WAS 118 PG/ML. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: GPT WAS 66.0 U/L, GGT WAS 146 U/L, LDH WAS 210 U/L, CPK WAS 778 U/L, CK-MB WAS 29.3 U/L, CK-MB WAS 29.3 U/L, CK-MB/TOTAL CK WAS 3.77%. SAMPLE ID (B)(6) RESULT, ON 27MAY, WAS 111 PG/ML. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: GPT WAS 54.1 U/L, GGT WAS 117 U/L, LDH WAS 207 U/L, CPK WAS 595 U/L, CK-MB WAS 24.1 U/L, CK-MB/TOTAL CK WAS 4.05%. SAMPLE ID (B)(6) RESULT, ON 30MAY, WAS 107 PG/ML. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: CPK WAS 271 U/L, CK-MB WAS 16.0 U/L. THE PATIENT HAD ANOTHER SAMPLE WITH INITIAL RESULT OF 106 PG/ML. A 1:2 DILUTION WAS 137.74, A 1:4 DILUTION WAS 135, AND A 1:8 DILUTION WAS 155.28 PG/ML. A SAMPLE WAS REPEATED AT ANOTHER LABORATORY AND THE RESULT WAS NEGATIVE. THE PATIENT WAS ALSO TESTED ON AN ACCUCHECK INSTRUMENT, AND THE RESULT WAS NEGATIVE. IT WAS NOTED THAT BECAUSE OF THE ELEVATED RESULTS THE PATIENT HAD AN UNNECESSARY CARDIAC CATHETERIZATION. THERE WAS NO REPORTED NEGATIVE IMPACT TO THE PATIENT BECAUSE OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366897 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 37587UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability ALNTY I PROCESSING MODU, 03R65-01, AI20508| ALNTY I PROCESSING MODU, 03R65-01, AI20508