BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2122870-2015-00862

    MDR report key: 5303208 · Received December 16, 2015

    Report

    Report Number
    2122870-2015-00862
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 27, 2015
    Report Date
    November 29, 2015
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, AND WEIGHT WERE NOT SUPPLIED BY THE CUSTOMER. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE DETERMINED THE DISPENSED SUBSTRATE VOLUME WAS LOW. THE SUBSTRATE PUMP VALVE WAS REPLACED. THE FSE DETERMINED THERE WERE ADDITIONAL VARIABLES EFFECTING SYSTEM PERFORMANCE. MINOR AND MAJOR PREVENTATIVE MAINTENANCE (PM) WERE COMPLETED. THE LUMINOMETER HIGH VOLTAGE CONTROL IS ADJUSTED AS PART OF THE PM. ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED INSTRUMENT AND ASSAY PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE IND FLAGGED TROPONIN I (ACCESS ACCUTNI+3) RESULTS IS DUE TO A SYSTEM MALFUNCTION, ALTHOUGH NO ONE PART CAN BE IMPLICATED AS THE SOLE CONTRIBUTOR IN THIS EVENT. A PM WAS PERFORMED ON THE INSTRUMENT AND MULTIPLE PARTS WERE EITHER SERVICED OR REPLACED TO RESOLVE THE ISSUE. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(9). ALL MDRS ASSOCIATED WITH THIS EVENT: 2122870-2015-00858, 2122870-2015-00859, 2122870-2015-00860, 2122870-2015-00861, 2122870-2015-00862, 2122870-2015-00863, 2122870-2015-00864.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER ON (B)(6) 2015 TO REPORT OBTAINING INDETERMINATE (IND) FLAGGED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TWENTY THREE (23) PATIENTS IN ASSOCIATION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4). THE CUSTOMER OBTAINED IND FLAGGED RESULTS FOR THREE (3) PATIENTS ON (B)(6) 2015. THE CUSTOMER STATED THE SAMPLES WERE RETESTED USING THE SAME ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, AND/OR AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER WAS NOT PROVIDED), AND NUMERICAL RESULTS WERE OBTAINED. THERE WAS NO REPORTED CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT IN ASSOCIATION WITH THE EVENT. MDRS 2122870-2015-00858, 2122870-2015-00859, 2122870-2015-00860, 2122870-2015-00861, 2122870-2015-00863, AND 2122870-2015-00864 WILL ADDRESS THE REMAINING IND FLAGGED PATIENT RESULTS. A SYSTEM CHECK PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS AND THE CUSTOMER STATED QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES BEFORE AND AFTER OBTAINING THE IND FLAGGED ACCESS ACCUTNI+3 RESULTS. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING SAMPLE COLLECTION, SAMPLE HANDLING OR SAMPLE PROCESSING. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.

    Patients

    Seq Age Sex Outcome Treatment
    1