BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVITY TROPONIN-I

    MDR report key: 19233409 · Received May 2, 2024

    Report

    Report Number
    3005094123-2024-00225
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    August 16, 2023
    Report Date
    June 5, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740194062
    PMA / PMN Number
    K202525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND ACCURACY TESTING FOR ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 56527UD00. THE TICKET SEARCH DETERMINED THAT THERE IS AS EXPECTED COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT OF LOT 56521UD00 WHICH CONTAINS THE SAME BULK MATERIAL AS LOT 56527UD00. ALL SPECIFICATIONS WERE MET INDICATING THAT LOTS 56521UD00/ 56527UD00 ARE PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 56527UD00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT ON MULTIPLE PATIENTS ON MULTIPLE ALINITY I PROCESSING MODULES. THE RESULTS PROVIDED WERE: ON (B)(6) 2023 FEMALE PATIENT SID (B)(6) INITIAL= < 2.7 NG/L /REPEATED==< 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6)=15.739 NG/L /POURED AND REPEATED=274.078 NG/L /ALIQUOT AND RE-CENTRIFUGED=< 2.7 NG/L /REDRAWN AND REPEATED SID L368126910= < 2.7 NG/L AND < 2.7 NG/L ON (B)(6) 2023 FEMALE PATIENT SID (B)(6) INITIAL=200.083 NG/L /RE-CENTRIFUGED AND REPEATED=4.458 NG/L ON (B)(6) 2023 FEMALE PATIENT SID (B)(6) ON (B)(6) INITIAL=326.551 NG/L /RE-CENTRIFUGED AND REPEATED= < 2.7 NG/L ON (B)(6) 2023 MALE PATIENT SID (B)(6) ON (B)(6) INITIAL=2820.099 NG/L /RE-CENTRIFUGED AND REPEATED= < 2.7 NG/L /REDRAWN AND REPEATED SID 2000815732= < 2.7 NG/L ON (B)(6) 2024 FEMALE PATIENT SID (B)(6) ON (B)(6) INITIAL=490.223 NG/L /RE-CENTRIFUGED AND REPEATED ON AI25677= < 2.7 NG/L /REDRAWN AND REPEATED SID 2001723339 ON BOTH ALINITY=< 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6) ON (B)(6)= < 2.7 NG/L LABORATORY REFERENCE RANGE FOR TROPONIN= FEMALE: < 14 NG/L; MALE= < 35 NG/L; CRITICAL= > 200 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT ON MULTIPLE PATIENTS ON MULTIPLE ALINITY I PROCESSING MODULES. THE RESULTS PROVIDED WERE: ON (B)(6) 2023 FEMALE PATIENT SID (B)(6) INITIAL= < 2.7 NG/L /REPEATED==< 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6) =15.739 NG/L /POURED AND REPEATED=274.078 NG/L /ALIQUOT AND RE-CENTRIFUGED=< 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6) = < 2.7 NG/L AND < 2.7 NG/L ON (B)(6) 2023 FEMALE PATIENT SID (B)(6) INITIAL=200.083 NG/L /RE-CENTRIFUGED AND REPEATED=4.458 NG/L. ON (B)(6) 2023 FEMALE PATIENT SID (B)(6) ON (B)(6) INITIAL=326.551 NG/L /RE-CENTRIFUGED AND REPEATED= < 2.7 NG/L. ON (B)(6) 2023 MALE PATIENT SID (B)(6) ON (B)(6) INITIAL=2820.099 NG/L /RE-CENTRIFUGED AND REPEATED= < 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6) = < 2.7 NG/L. ON (B)(6) 2024 FEMALE PATIENT SID (B)(6) ON (B)(6) INITIAL=490.223 NG/L /RE-CENTRIFUGED AND REPEATED ON (B)(6) = < 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6) ON BOTH ALINITY=< 2.7 NG/L /REDRAWN AND REPEATED SID (B)(6) ON (B)(6) = < 2.7 NG/L. LABORATORY REFERENCE RANGE FOR TROPONIN= FEMALE: < 14 NG/L; MALE= < 35 NG/L; CRITICAL= > 200 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411285 ALINITY I STAT HIGH SENSITIVITY TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 56527UD00 00380740194062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)