BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 10370770 · Received August 5, 2020

    Report

    Report Number
    3016438761-2020-00158
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING A FALSELY ELEVATED STAT HIGH SENSITIVE TROPONIN-I RESULT ON THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE R2 AND STAT SYRINGE ASSEMBLIES WERE LEAKING AND NEEDED TO BE REPLACED, WHICH RESOLVED THE CUSTOMER'S COMPLAINT. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER, SO A CORRECTION WAS MADE TO THE ANALYZER USED TO REPEAT THE PATIENT RESULTS IN SECTION B5. NARRATIVE CHANGED FROM "FROM ANOTHER ARCHITECT C4000 ANALYZER" TO "FROM ANOTHER ARCHITECT I2000SR ANALYZER, SERIAL NUMBER (B)(6)."

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S CUT OFF RANGE IS 16 NG/L FOR FEMALES AND 34 NG/L FOR MALES): SAMPLE ID 6081556 INITIAL RESULT WAS 1886 NG/L, REPEATS, FROM ANOTHER ARCHITECT I2000SR ANALYZER, SERIAL NUMBER (B)(6), WERE 5.4, 5.2, AND 5.6 NG/L. THE PATIENT WAS REDRAWN TWICE, SAMPLE ID 34318442 RESULT WAS 7.5 NG/L AND SAMPLE ID 6082173 RESULT WAS 9.9 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S CUT OFF RANGE IS 16 NG/L FOR FEMALES AND 34 NG/L FOR MALES): SAMPLE ID (B)(6) INITIAL RESULT WAS 1886 NG/L, REPEATS, FROM ANOTHER ARCHITECT C4000 ANALYZER, WERE 5.4, 5.2, AND 5.6 NG/L. THE PATIENT WAS REDRAWN TWICE, SAMPLE ID (B)(6) RESULT WAS 7.5 NG/L AND SAMPLE ID (B)(6) RESULT WAS 9.9 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830419 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I,| ARCHITECT STAT HIGH SENSITIVE TROPONIN-I,| ARCHITECT STAT HIGH SENSITIVE TROPONIN-I,| LIST# 03P25-27, LOT# 14530UI00| LIST# 03P25-27, LOT# 14530UI00| LIST# 03P25-27, LOT# 14530UI00