BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 7024262 · Received November 13, 2017

    Report

    Report Number
    3002769706-2017-00359
    Event Type
    Injury
    Date Received
    November 13, 2017
    Report Date
    May 18, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: REVIEW OF THE DEVICE HISTORY RECORD AND INTERNAL COMPLAINT DATA IDENTIFIED NO DISCREPANCY OR ANOMALY. THE CUSTOMER SAMPLE WAS NOT RETURNED FOR EVALUATION. BIOMÉRIEUX PERFORMED TESTING ON AN INTERNAL SAMPLE THAT IS SIMILAR TO THE CUSTOMER SAMPLE. THIS SERUM (SCI4) WAS TESTED IN SEVERAL CONDITIONS: 1. DILUTION IN TWO (2) MALE SAMPLES USED AS DILUENT OR SERUM FREE (REF.66581), THERE IS NO DIFFERENCE BETWEEN RESULTS OBTAINED WITH SERUM FREE AND MALE SERUM. RFV/ TITER; RANGES S1; 2865 RFV ; 2202-3933 RFV. C1; 117.76 PG/ML; 100.43-155.09 PG/ML. MALE SAMPLE (B)(6); 15.30 PG/ML; NA. MALE SAMPLE (B)(6); 11.98 PG/ML; NA. SERUM FREE REF 66581; < 9PG/ML; NA. SCI4 PURE; 1315.48 PG/ML 1411 PG/ML (1190-1632). SCI4 ½ SH (MALE SAMPLE); 1359.78 PG/ML (679.89 X 2) NA. SCI4 ½ S (SERUM FREE ); 1346.38 PG/ML (673.19 X 2); NA. 2. WITHOUT USING THE SPR® A RESULT SIMILAR TO THE CUSTOMER'S RESULT (> 11010 PMOL/L) SCI4 IS OBTAINED: RFV; TITER PG/ML; TITER PMOL/L: SCI4 PURE; 555; 1315.48; 4827.81. SCI4 WITHOUT SPR; 1 >3000; >11010; 3. TESTING WITH A REDUCED SAMPLE AMOUNT DID NOT SHOW A SIMILAR ISSUE AS OBSERVED BY THE CUSTOMER. TO CONCLUDE, ACCORDING TO THE INFORMATION AND DATA REFERENCED ABOVE, THE ROOT CAUSE IS UNKNOWN BECAUSE THE CUSTOMER SAMPLE WAS NOT SUBMITTED FOR TESTING. IT IS LIKELY THAT THE CUSTOMER FORGOT TO ADD THE SPR DURING THE FIRST ANALYSIS OR A FRAGMENT OF FIBRIN MAY HAVE IMPEDED PIPETTING BY THE SPR AND THE INSTRUMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® ESTRADIOL II (REFERENCE 30431). THE CUSTOMER REPORTED A STRANGE RESULT WHEN THE TEST WAS RUN ON MINIVIDAS®. THE RESULT WAS LESS THAN 11,000 PMOL/L WHICH WAS EXPECTED WITH 24 FOLLICLES, WHEREAS WHEN DILUTED WITH SERUM FREE (1:5) THE RESULT WAS 3,200 PMOL/L. A SECOND TEST WAS CONDUCTED WITHOUT ENTERING THE DILUTION AND THE VALUE WAS 600 PMOL/L (AN EXPECTED VALUE IF THE MACHINE COUNTED WITH THE DILUTION). A THIRD TEST WAS THEN DONE WITHOUT DILUTING THE SAMPLE AND THE RESULT WAS 4,000 PMOL/L INSTEAD OF 11,000 PMOL/L. THERE WAS A DELAY IN REPORTING THE RESULT TO THE PHYSICIAN. IT IS UNKNOWN IF TREATMENT WAS IMPACTED OR IF THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806391 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1005808490

    Patients

    Seq Age Sex Outcome Treatment
    1