BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HFSH REAGENT

    MDR report key: 8524260 · Received April 17, 2019

    Report

    Report Number
    2122870-2019-01070
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    January 31, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGJ
    UDI-DI
    15099590575236
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY: THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. DEVICE EVALUATED BY MFR: THE ACCESS HFSH REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER PERFORMED LINEAR DILUTION TESTING ON THE PATIENT'S SAMPLE AND OBTAINED NON-LINEAR RESULTS SUGGESTING A PATIENT-SOURCE INTERFERENT. IN ADDITION, THE CUSTOMER SENT SAMPLE TO A REFERENCE LABORATORY WHO PRE-TREATED THE SAMPLE WITH BLOCKING AGENTS. THE RESULT OBTAINED WAS SIGNIFICANTLY LOWER THAN THE CUSTOMER'S RESULT AGAIN SUGGESTING THE PRESENCE OF A PATIENT-SOURCE INTERFERENT OF UNKNOWN ORIGIN. IN CONCLUSION, THE CAUSE OF THIS EVENT IS DUE TO AN UNKNOWN PATIENT-SOURCE INTERFERENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) TO REPORT OBTAINING A HIGHER THAN EXPECTED FOLLICLE STIMULATING HORMONE (ACCESS HFSH) RESULT FOR ONE FEMALE PATIENT ON THE LABORATORY¿S ACCESS 2 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). THE FIRST ACCESS HFSH RESULT QUESTIONED WAS ON (B)(6) 2019. THE CUSTOMER TOOK THE PATIENT OFF OF THEIR BIRTH-CONTROL MEDICATION AT THIS TIME. ANOTHER SAMPLE WAS COLLECTED AND TESTED FOR ACCESS HFSH AGAIN; ANOTHER HIGHER THAN EXPECTED RESULT WAS OBTAINED. THE CUSTOMER PERFORMED LINEAR DILUTIONS AND NOTED THAT THE RESULTS OBTAINED WERE NOT LINEAR SUGGESTING THAT A PATIENT-SOURCE INTERFERENT WAS PRESENT. THE PATIENT THEN HAD AN MRI (MAGNETIC RESONANCE IMAGING) OF THE HEAD PERFORMED WHICH WAS NORMAL (IT IS UNKNOWN IF CONTRAST DYE WAS USED). IN ADDITION, THE PATIENT RECEIVED TREATMENT WITH A GNRH (GONADOTROPIN-RELEASING HORMONE) ANTAGONIST, HOWEVER, THE ACCESS HFSH RESULT WAS STILL HIGHER THAN EXPECTED. ON (B)(6) 2019 A THIRD SAMPLE WAS TESTED FOR THE ACCESS HFSH ASSAY AND THE RESULT WAS SIMILAR; STILL ELEVATED. THIS SAMPLE WAS ALSO SENT TO A REFERENCE LABORATORY WHICH USED A DIFFERENT METHODOLOGY (TYPE UNKNOWN) AND PRETREATMENT WITH A BLOCKING REAGENT. THE RESULT WAS MUCH LOWER THAN THE ACCESS HFSH RESULT AND MORE IN-LINE WITH THE CUSTOMER¿S EXPECTATION BASED UPON THE PATIENT¿S CLINICAL PRESENTATION. THERE WAS A CHANGE IN PATIENT CARE/MANAGEMENT AS THE PATIENT WAS TAKEN OFF OF THEIR BIRTH-CONTROL MEDICATION, UNDERWENT AN MRI OF THE HEAD AND WAS TREATED WITH A GNRH ANTAGONIST. THERE WAS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION AS TO THE INSTRUMENT¿S PERFORMANCE INCLUDING QC (QUALITY CONTROL), CALIBRATIONS OR SYSTEM CHECK. HOWEVER, THERE WERE NO REPORTS OF ISSUES WITH HARDWARE OR OTHER PATIENT RESULTS OR ASSAYS. SAMPLE COLLECTION AND PREPARATION INFORMATION WAS NOT SUPPLIED INCLUDING SAMPLE TYPE, CENTRIFUGATION TIME AND SPEED AND STORAGE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317010 ACCESS HFSH REAGENT RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE CGJ BECKMAN COULTER 724813 15099590575236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other