BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 10560792 · Received September 21, 2020

    Report

    Report Number
    3016438761-2020-00231
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING WHICH INCLUDED REPLACED THE VALVE, MANIFOLD KIT (PN 7-77612-03) AND THE VALVE, BYPASS, 2 WAY (LN 7-200607-01) WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT I1000SR, SERIAL NUMBER (B)(6), REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT RESULTS, NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF HISTORICAL DATA FOR THE ARCHITECT I1000SR DID NOT IDENTIFY ANY TRENDS. A REVIEW OF HISTORICAL DATA FOR THE REPLACEMENT PART THE VALVE, MANIFOLD KIT (PN 7-77612-03) AND THE VALVE, BYPASS, 2 WAY (LN 7-200607-01) DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LIKELY CAUSE PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE REPLACED PART THE VALVE, MANIFOLD KIT (PN 7-77612-03) AND THE VALVE, BYPASS, 2 WAY (LN 7-200607-01) OR THE ARCHITECT I1000SR PROCESSING MODULE, SERIAL NUMBER(B)(6)WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. 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 OBSERVED DECREASED ARCHITECT TOTAL B-HCG RESULTS ON ONE PATIENT, AND INSTRUMENT ERROR MESSAGE 1007 AND 1008. THE RESULTS PROVIDED WERE: ON (B)(6) 2020, TOTAL B-HCG=<2 IU/L (<5.00 MIU/ML=NEGATIVE). ON (B)(6) 2020, REPEATED RESULT=25 IU/L (>OR=25.00 MIU/ML=POSITIVE). ON (B)(6) 2020, PREVIOUS RESULT=32 IU/L (POSITIVE). ON (B)(6) 2020, TOTAL B-HCG RESULT=6 IU/L (NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027113 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 1L86-40 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC BHCG RGT (100T), 07K78-25.| ARCHITECT TOTAL B-HCG.| LIST # 07K78-25, LOT # UNKNOWN.| ARCHITECT TOTAL B-HCG| LIST # 07K78-25, LOT # UNKNOWN