BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2122870-2017-00017

    MDR report key: 6357038 · Received February 24, 2017

    Report

    Report Number
    2122870-2017-00017
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    November 3, 2016
    Report Date
    February 21, 2017
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, OR WEIGHT. (B)(6). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED HARDWARE PARTS TO INCLUDE REPLACEMENT OF THE WASH CAROUSEL BEARINGS THAT WERE IDENTIFIED TO HAVE BEEN DAMAGED/DETERIORATED BY SPILLED WASH BUFFER. THE DAMAGED WASH CAROUSEL BEARINGS WERE CAUSING ROUGH MOVEMENTS OF THE REACTION VESSELS (RVS) AND ROUGH MOVEMENTS OF THE WASH CAROUSEL RESULTING IN SPLASHING OF THE REACTANTS. THERE IS SUFFICIENT EVIDENCE TO DETERMINE A HARDWARE MALFUNCTION AS THE CAUSE OF THIS EVENT. (B)(4). ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 2122870-2017-00010, 2122870-2017-00011, 2122870-2017-00012, 2122870-2017-00015, 2122870-2017-00016, 2122870-2017-00017, 2122870-2017-00018, 2122870-2017-00019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED DIMERIC INHIBIN A (ACCESS INHIBIN A) RESULTS HAD BEEN GENERATED FOR MULTIPLE PATIENTS ON THE CUSTOMER'S ACCESS2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER RECEIVED THE LATEST REPORT FROM THEIR EXTERNAL QUALITY ASSURANCE (EQA) PROGRAM FOR ANTENATAL SCREENING AND DETERMINED THAT THEY HAD REPORTED AN EQA ACCESS INHIBIN A SURVEY RESULT THAT WAS 5 TIMES THE INSTRUMENT MEDIAN. UPON RECEIPT OF THIS REPORT, THE CUSTOMER REPEATED PATIENT SAMPLES THAT WERE TESTED FOR ACCESS INHIBIN A WHO WERE REPORTED AS AN INCREASE RISK. REPEAT ANALYSIS OF SOME THE PATIENT SAMPLES RECOVERED WITH LOWER RESULTS, NO LONGER IN THE INCREASED RISK CATEGORY. CALIBRATION DATA WAS NOT PROVIDED. SYSTEM CHECKS PERFORMED ON (B)(4) 2017 FAILED TO MEET SPECIFICATIONS WITH ELEVATED % CV RESULTS. THERE WERE SOME INSTANCES OF ERRATIC ACCESS INHIBIN A QUALITY CONTROL (QC) RESULTS GENERATED AROUND THE TIME OF THIS EVENT. PATIENT SAMPLE COLLECTION AND PROCESSING INFORMATION WAS NOT PROVIDED. THIS REPORT ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULT OBTAINED FOR ONE PATIENT (IDENTIFIED AS PATIENT 2) ON (B)(6) 2016. ADDITIONAL REPORTS ARE AS FOLLOWS: 2122870-2017-00010 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2017 FOR ONE PATIENT. 2122870-2017-00011 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2016 FOR ONE PATIENT. 2122870-2017-00012 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2017 FOR THREE PATIENTS. 2122870-2017-00015 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2017 FOR ONE PATIENT. 2122870-2017-00016 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2017 FOR ONE PATIENT. 2122870-2017-00018 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2016 FOR ONE PATIENT. 2122870-2017-00019 ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS INHIBIN A RESULTS OBTAINED ON (B)(6) 2016 FOR ONE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1