BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 11953413 · Received June 7, 2021

    Report

    Report Number
    3016438761-2021-00206
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. INITIAL REPORTER POSTAL CODE : (B)(6) POSTAL CODE IS LESS THAN 5 DIGITS, A LEADING ZERO IS ADDED DUE TO THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER OBSERVED ERROR CODE 3700 AND SERVICE WAS DISPATCHED. SERVICE INSPECTED THE INSTRUMENT AND DETERMINED THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 THE LIKELY CAUSE AND REPLACED. PART REPLACEMENT RESOLVED THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR ISR05816. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. TRACKING AND TRENDING WAS REVIEWED AND DID NOT IDENTIFY ANY TRENDS FOR THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 OR FOR THE ARCHITECT I2000SR ANALYZER (ISR05816). DEVICE HISTORICAL ANALYSIS WAS REVIEWED AND DETERMINED NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED FOR THE ISSUE 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. A1: PATIENT IDENTIFIER: INITIAL: NI / UPDATED: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT ANTI-HBS RESULTS FOR A PATIENT WHILE RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED ON (B)(6) 2021 (ANTI-HBS REFERENCE RANGE: >/= 10.00 MIU/ML IS PROTECTIVE): SID (B)(6) = ANTI-HBS INITIAL RESULT = 10.65 MIU/ML, REPEAT = 4.56 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841399 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC ANTI-HBS RGT 2000T, (B)(4)| ARC ANTI-HBS RGT 2000T, (B)(4)