BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 11885118 · Received May 26, 2021

    Report

    Report Number
    3016438761-2021-00195
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUS REPORT INADVERTENTLY OMITTED CONCOMITANT INFORMATION AND MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2021-00023-00 UNDER A DIFFERENT SUSPECT DEVICE. MULTIPLE PATIENTS WERE INVOLVED IN THIS EVENT. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND OBSERVED LEAKING FROM WASH ZONE THREE VALVE. THE FSR REPLACED THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT I1000SR, SERIAL NUMBER (B)(4) REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE VALVE, MANIFOLD KIT (ROHS) DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT I1000SR DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 OR THE ARCHITECT I1000SR, SERIAL NUMBER (B)(4) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER GENERATED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR THREE PATIENTS. THE CUSTOMER USES THE REFERENCE RANGES MALE: 0-0.033 NG/ML FEMALE: 0-0.013 NG/ML. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) (FEMALE PATIENT) INITIAL RESULT 0.011 NG/ML, REPEATED 0.029, 0.002, AND 0.000 NG/ML. SID (B)(6) (FEMALE PATIENT) INITIAL RESULT 0.039 NG/ML, REPEATED 0.003, 0.003, AND 0.000 NG/ML. SID (B)(6) (MALE PATIENT) INITIAL RESULT 0.018 NG/ML, REPEATED 0.035, 0.000, AND 0.003 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778745 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-40 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC TROP RGT, 02K41-27, (B)(4)