BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 5770645 · Received July 5, 2016

    Report

    Report Number
    3002769706-2016-00114
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Report Date
    June 24, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN FRANCE REPORTED DISCREPANT (HIGHER THAN EXPECTED) RESULTS IN ASSOCIATION WITH THE VIDAS ESTRADIOL II ASSAY. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF THE MANUFACTURING BATCH RECORD FOR THE REFERENCED LOT INDICATED NO ANOMALY ASSOCIATED WITH THE BATCH. QUALITY PRODUCT LABORATORY CHECKED THE BEHAVIOR OF FIVE INTERNAL SAMPLES, (CONCENTRATIONS BETWEEN 1.56 TO 3.54 MG/L), FOR SIX RANDOM BATCHES OF VIDAS E2 II. THE CUSTOMER'S RESULTS SHOW VERY GOOD CORRELATION WITH THE PEER GROUP FOR THE PROBIOQUAL SAMPLES (B)(6). PROBIOQUAL MENTIONED THAT (B)(6) ARE IN FACT THE SAME SAMPLES. THE QUALITY PRODUCT LABORATORY TESTED SAMPLES (B)(6) ON TWO BATCHES VIDAS E2II 100440710/161124-0 (CUSTOMER BATCH) AND 1004680190/ 170129-0 (BATCH WITH DIFFERENT RAW MATERIAL). ALL RESULTS ARE IN THE EXPECTED RANGES. VIDAS E2 II BATCH 161124-0/1004490710 IS WITHIN THE EXPECTED SPECIFICATIONS. IN ADDITION, THE CUSTOMER INFORMED BIOMÉRIEUX THAT ONE OF HIS TECHNICIANS HAD HORMONE THERAPY AND SHOULD NOT PROCESS EQA. INDIRECT CONTAMINATION IS POSSIBLE BY THE TECHNICIAN FOLLOWING HORMONE THERAPY, AND MAY BE THE ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS WITH THE VIDAS® ESTRADIOL II (REFERENCE (B)(4)). THE CUSTOMER REPORTS WRONG RESULTS WITH THE EEQ PBQ FOR ESTRADIOL II FOR MD07/MD08 (RESULTS: 506.40 PG/ML (1129 RFV) AND 1457.42 PG/ML (540 RFV) RESPECTIVELY. THE CUSTOMER REPORTS THAT TWO (2) CALIBRATIONS WERE PERFORMED ON (B)(6) AND FELL WITHIN ACCEPTABLE LIMITS. BASED ON THE INFORMATION PROVIDED, THERE WAS NO ADVERSE EVENTS, NEGATIVE PATIENT IMPACT OR DELAY IN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425428 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1004490710

    Patients

    Seq Age Sex Outcome Treatment
    1