BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 8294098 · Received January 31, 2019

    Report

    Report Number
    1628664-2019-00079
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 18, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT TEXT, THE ABBOTT FIELD SERVICE ENGINEER (FSE) FOUND THAT THE WASHZONE1 PRECISION WAS NOT PRECISE. THE FSE HAD THE CUSTOMER REPLACE THE VALVE MANIFOLD KIT (PN 7-77612-03). THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS SINCE THE VALVE, MANIFOLD KIT WAS REPLACED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4) SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THE ARCHITECT SYSTEMS OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS; AND ADDRESSES OBSERVED PROBLEMS FOR ERRATIC RESULTS, INCLUDING, BUT NOT LIMITED TO THE TROUBLESHOOTING PERFORMED BY SERVICE. THE ARCHITECT I SYSTEMS SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR REPLACEMENT OF THE VALVE, MANIFOLD KIT. A 12-MONTH SEARCH FOR SIMILAR COMPLAINTS FOR REPLACEMENT OF THE VALVE, MANIFOLD KIT DID NOT IDENTIFY ANY SIMILAR COMPLAINTS OR TRENDS. A REVIEW OF TRACKING AND TRENDING FOR THE I2000SR PLATFORM DID NOT IDENTIFY ANY TRENDS. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4) OR THE VALVE MANIFOLD KIT (PN 7-77612-03).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT BHCG RESULTS ON ONE PATIENT WHICH UPON REPEAT TESTING WAS NEGATIVE. THE RESULTS PROVIDED WERE: ON (B)(6) 2019, SID: (B)(6), INITIAL = 64.54 / 28.08MIU/ML (>/=25.00MIU/ML = POSITIVE) / 11.47MIU/ML (>5.00 AND < 25.00=GRAYZONE) / THEN REPEATED X3 = <1.20MIU/ML (</=5.00MIU/ML = NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87724 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT B-HCG| ARCHITECT B-HCG