BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00093

    MDR report key: 6461960 · Received April 5, 2017

    Report

    Report Number
    1628664-2017-00093
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 8, 2017
    Report Date
    May 19, 2017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT FIELD SERVICE INDIVIDUAL WAS DISPATCHED TO THE ACCOUNT AND FOUND THE ANALYZER PRE-TRIGGER CHECK TEST FAILED AND OBSERVED THAT THE PRE-TRIGGER HOSE FITTING ATTACHED TO THE MANIFOLD HAD LEAKS. THE TUBING, PRE-TRIG FLUSH TO UPPER MANIFOLD, (ROHS) (PART 7-200162-01) WAS TIGHTENED TO RESOLVE THE ISSUE. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A DEVICE HISTORY REVIEW, A LABELING REVIEW, INSTRUMENT LOG REVIEW, AND AN INSTRUMENT SERVICE REVIEW. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE AND THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS; AND ADDRESSES TROUBLESHOOTING OF ERRATIC RESULTS, INCLUDING SUGGESTING TIGHTENING OF THE TUBING, PRE-TRIG FLUSH TO UPPER MANIFOLD, (ROHS). MAINTENANCE LOG REVIEW SHOWED THE ANALYZER DAILY MAINTENANCE WAS NOT COMPLETED BY THE CUSTOMER ON THE DAYS THE FALSELY NONREACTIVE SPECIMEN RESULTS WERE OBTAINED, (B)(6) 2017. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. SERVICE HISTORY REVIEW IDENTIFIED NO CONTRIBUTING FACTORS TO THE CUSTOMER ISSUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    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 MULTIPLE (B)(6) PATIENT RESULTS WHILE USING THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (S/CO). PATIENT 1: SID (B)(6) (TESTED MARCH 14, 2017) 0.83 ((B)(6)). SID (B)(6) WAS INITIALLY TESTED ON MARCH 8, 2017 AND WAS (B)(6) (707.92). REPEATED USING ANOTHER ANALYZER (SID 211302) 658.02 ((B)(6)). PATIENT 2: SID (B)(6) (TESTED (B)(6) 2017) 0.31 ((B)(6)). THE SAME SPECIMEN WAS TESTED ON (B)(6) 2017 (SID (B)(6)) AND WAS (B)(6) ON THE SAME ANALYZER (764.88) AND ANOTHER ANALYZER 673.78. PATIENT 3: SID (B)(6) (TESTED (B)(6) 2017) 0.00 ((B)(6)) THE SAME SPECIMEN WAS TESTED ON (B)(6) 2017 (SID (B)(6)) AND WAS (B)(6) (5.27) ON THE SAME ANALYZER AND ANOTHER ANALYZER (5.24). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT HIV AG/AB COMBO REAGENT| LIST NUMBER 04J27-27| LOT NUMBER 70049LI00