BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00426

    MDR report key: 7004654 · Received November 6, 2017

    Report

    Report Number
    1628664-2017-00426
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    September 23, 2017
    Report Date
    December 12, 2017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND FOUND LEAKING PARTS THAT WERE NOT WORKING, VALVE, BYPASS, 2 WAY [PART 7-200607-01] AND VALVE, MANIFOLD KIT [PART 7-77612-03]. THESE PARTS WERE DETERMINED TO BE THE LIKELY CAUSE OF THE CUSTOMER ISSUE AND WERE REPLACED. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, DEVICE HISTORY REVIEW, FIELD DATA REVIEW, INSTRUMENT SERVICE REVIEW, AND LABELING REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE, FOR THE REPLACED PARTS, OR FOR THE ANALYZER. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. REVIEW OF FIELD DATA FOR THE LAST 12 MONTHS SHOWED THE CALCULATED ERRATIC RESULTS RATES FOR THE ARCHITECT I2000SR ANALYZER WERE BELOW THE ESTABLISHED UPPER CONTROL LIMIT. SERVICE HISTORY REVIEW IDENTIFIED NO CONTRIBUTING FACTORS TO THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. SPECIMEN 2 (DRAWN/TESTED ON (B)(6) 2017) (B)(6) (NO SPECIFIC VALUE WAS PROVIDED) SPECIMEN 1 (TESTED (B)(6) 2017) INITIAL (B)(6), REPEAT (B)(6). NO NEUTRALIZING CONFIRMATORY TEST RESULTS WERE PROVIDED FOR SPECIMEN 1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1