BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT MYOGLOBIN REAGENT KIT

    MDR report key: 17864799 · Received October 3, 2023

    Report

    Report Number
    1415939-2023-00054
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 13, 2023
    Report Date
    November 1, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DDR
    UDI-DI
    00380740003302
    PMA / PMN Number
    K042924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED ARCHITECT STAT MYOGLOBIN RESULT 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 IN-HOUSE TESTING OF A RETAINED KIT OF THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 56175UN22, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT STAT MYOGLOBIN REAGENT, LOT NUMBER 56175UN22, WAS IDENTIFIED.SECTION G1 CONTACT INFORMATION WAS UPDATED TO REFLECT THE CURRENT CONTACT (B)(6).

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION E1 - PHONE COMPLETE ENTRY = (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT MYOGLOBIN RESULT FOR A MALE PATIENT, WHO HAD NO MYOCARDIAL INFARCTION SYMPTOMS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS <154.9 NG/ML): INITIAL RESULT WAS >1200, 1:10 DILUTION RESULT WAS 4192 NG/ML. THE SAMPLE WAS TESTED WITH A MICROPOINT TEST, AND THE RESULT WAS 0.15 NG/ML, REFERENCE RANGE IS <0.3 NG/ML. THE SAMPLE WAS ALSO TESTED WITH A NANJING GETEIN BIOTECH POCT INSTRUMENT, AND THE RESULT WAS >600 NG/ML. THE SAMPLE WAS SENT OUT FOR TESTING USING A ROCHE ASSAY AND THE RESULT WAS 1751.0 NG/ML, REFERENCE RANGE IS 28-72 NG/ML. THE SAMPLE WAS ALSO TESTED WITH A BECKMAN ASSAY AND THE RESULT WAS 2187.9 NG/ML. IT WAS NOTED THAT BASED ON THE ELEVATED RESULTS, THE PATIENT RECEIVED AN ELECTROCARDIOGRAM AND INFUSION THERAPY. THE PATIENT HAD NO SYMPTOMS AND HAD SINCE BEEN DISCHARGED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT MYOGLOBIN RESULT FOR A MALE PATIENT, WHO HAD NO MYOCARDIAL INFARCTION SYMPTOMS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS <154.9 NG/ML): INITIAL RESULT WAS >1200, 1:10 DILUTION RESULT WAS 4192 NG/ML. THE SAMPLE WAS TESTED WITH A MICROPOINT TEST, AND THE RESULT WAS 0.15 NG/ML, REFERENCE RANGE IS <0.3 NG/ML. THE SAMPLE WAS ALSO TESTED WITH A NANJING GETEIN BIOTECH POCT INSTRUMENT, AND THE RESULT WAS >600 NG/ML. THE SAMPLE WAS SENT OUT FOR TESTING USING A ROCHE ASSAY AND THE RESULT WAS 1751.0 NG/ML, REFERENCE RANGE IS 28-72 NG/ML. THE SAMPLE WAS ALSO TESTED WITH A BECKMAN ASSAY AND THE RESULT WAS 2187.9 NG/ML.. IT WAS NOTED THAT BASED ON THE ELEVATED RESULTS, THE PATIENT RECEIVED AN ELECTROCARDIOGRAM AND INFUSION THERAPY. THE PATIENT HAD NO SYMPTOMS AND HAD SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553738 ARCHITECT STAT MYOGLOBIN REAGENT KIT MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL DDR ABBOTT LABORATORIES 56175UN22 00380740003302

    Patients

    Seq Age Sex Outcome Treatment
    1 Male ARC I1000SR MOD, 01L86-01, (B)(6)| ARC I1000SR MOD, 01L86-01, (B)(6)