BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 15438087 · Received September 16, 2022

    Report

    Report Number
    3016438761-2022-00426
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 3, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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.

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE LEAKING ASSY, TRIGGER_ PRE-TRIGGER HEATER, COMPLETE (ROHS) (7-200599-02), SYRINGE ASSY (7-77650-09) AND 100UL TRIGGER PUMP (ROHS) (7-96344-02), WHICH RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT I PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT I PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ASSY, TRIGGER_ PRE-TRIGGER HEATER, COMPLETE (ROHS) SYRINGE ASSY AND 100UL TRIGGER PUMP (ROHS). THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. THE ARCHITECT I SYSTEM SERVICE MANUAL CONTAINED ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, REPLACEMENT AND VERIFICATION OF THE ASSY, TRIGGER_ PRE-TRIGGER HEATER, COMPLETE (ROHS) SYRINGE ASSY AND 100UL TRIGGER PUMP (ROHS). A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT I SERIAL NUMBER (B)(6) , OR THE ASSY, TRIGGER_ PRE-TRIGGER HEATER, COMPLETE (ROHS) (7-200599-02), SYRINGE ASSY (7-77650-09) AND 100UL TRIGGER PUMP (ROHS) (7-96344-02).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ON ONE FEMALE PATIENTS. THE RESULTS PROVIDED WERE: INITIAL=8 NG/L /REPEATED=17 NG/L, 28 NG/L, 25 NG/L, 41 NG/L, 20 NG/L /SEND SPECIMEN TO ANOTHER FACILITY=9 NG/L. LABORATORY REFERENCE RANGE FOR FEMALE: < 16 NG/L; MALE: <35 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435234 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-40 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC TROPONIN RGT 100 TE, 03P25-26, UNKNOWN| ARC TROPONIN RGT 100 TE, 03P25-26, UNKNOWN