BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 11708782 · Received April 22, 2021

    Report

    Report Number
    3016438761-2021-00153
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 10, 2021
    Report Date
    May 20, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE INSPECTED THE ARHCITECT I2000SR INSTRUMENT (B)(6) AND DETERMINED THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 THE LIKELY CAUSE. PART REPLACEMENT RESOLVED THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. THE TRENDING REVIEW IDENTIFIED NO TRENDS FOR THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 AND THE ARCHITECT I2000SR INSTRUMENT (B)(6) RELATED TO THE ISSUE. THE DEVICE HISTORICAL ANALYSIS WAS REVIEWED AND IDENTIFIED NO NON-CONFORMANCES OR DEVIATIONS FOR THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 OR THE ARCHITECT I2000SR INSTRUMENT (B)(6) ASSOCIATED WITH THE COMPLAINT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT STAT MYOGLOBIN AND ARCHITECT STAT CK-MB RESULTS FOR A PATIENT WHILE RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2021 = INITIAL PATIENT SAMPLE (ID UNKNOWN) = MYOGLOBIN RESULT = < 1 NG/ML, CKMB RESULT = < 0.1 NG/ML; REPEAT RESULTS = MYOGLOBIN = 246.8 NG/ML, CKMB = 12.2 NG/ML. THE REFERENCE RANGE FOR MYOGLOBIN FOR FEMALE IS < 106 NG/ML AND MALE IS < 154.9 NG/ML. THE REFERENCE RANGE FOR CKMB FOR FEMALE IS < 3.1 NG/ML AND MALE IS < 5.2 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603621 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC CKMB RGT, 02K42-28, 01169UN20| ARC CKMB RGT, 02K42-28, 01169UN20| ARC MYOGLOBIN RGT, 02K43-20, 99638UN20| ARC MYOGLOBIN RGT, 02K43-20, 99638UN20