BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL BHCG (5TH IS)

    MDR report key: 4082703 · Received September 11, 2014

    Report

    Report Number
    2122870-2014-00652
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K130020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS REPORTED INCIDENT WAS INADVERTENTLY FILED. THE EVENT IS DETERMINED TO BE NOT REPORTABLE AS FURTHER EVALUATION DEMONSTRATED PATIENT SAMPLE INTERFERENCE AS THE ROOT CAUSE OF THE ELEVATED BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) PATIENT RESULTS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS TOTAL BHCG (5TH IS) DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER SUPPLIED BECKMAN COULTER WITH THE PATIENT'S SAMPLES FOR FURTHER ANALYSIS. THE PATIENT'S SAMPLES WERE CENTRIFUGED AND TESTED NEAT AND CONFIRMED THE CUSTOMER'S TBHCG (5TH IS) AND TBHCG RESULTS. AN INTERFERENCE TESTING, UTILIZING A MIX OF DIFFERENT BLOCKERS, WAS THEN PERFORMED FOR THE TBHCG (5TH IS) ASSAY. THIS ANALYSIS DEMONSTRATED THE PRESENCE OF INTERFERING SUBSTANCES SINCE AT LEAST ONE OF THE INTERFERENCE BLOCKERS, USED IN THE TEST, SIGNIFICANTLY LOWERED THE SIGNAL. HOWEVER, THE SIGNAL WAS NOT COMPLETELY SUPPRESSED WHEN ADDING ALKALINE PHOSPHATASE MUTEIN. ONE SAMPLE WAS ANALYZED BY GEL FILTRATION CHROMATOGRAPHY (GFC OR SIZE EXCLUSION CHROMATOGRAPHY). THE CHROMATOGRAPHIC ANALYSIS INDICATED THAT ELUTION FRACTIONS, CORRESPONDING TO THE MOLECULAR WEIGHT OF TBHCG (46 KDA), WERE NOT REACTIVE WITH THE ACCESS TBHCG (5TH IS) ASSAY. HOWEVER, ELUTION FRACTIONS CORRESPONDING TO THE MOLECULAR WEIGHT OF IGM AND IGG (750 KDA AND 150 KDA) WERE REACTIVE WITH THE ACCESS TBHCG (5TH IS) ASSAY. ELUTION FRACTIONS WERE ALSO TESTED ON PREVIOUS TBHCG ASSAY - NONE REACTED WITH THE TBHCG ASSAY. IN CONCLUSION, THE INVESTIGATION DEMONSTRATED AN INTERFERENCE, RELATED TO ALKALINE PHOSPHATASE, CONTRIBUTED TO INCREASE THE SIGNAL. CHROMATOGRAPHIC ANALYSIS CONFIRMED THAT AN INTERFERING SUBSTANCE WAS REACTING WITH THE TBHCG (5TH IS) ASSAY.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED REPEATABLE ELEVATED BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESSTOTAL BHCG (5TH IS) ASSAY USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS WERE DISCORDANT WITH PREVIOUS PATIENT RESULTS OBTAINED WITH THE ACCESS TBHCG ASSAY. THE CUSTOMER STATED THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED ALL OF THE SYSTEM PARAMETERS, INCLUDING QUALITY CONTROL (QC), CALIBRATION, AND SYSTEM CHECK, WERE WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO SYSTEM ISSUES WERE REPORTED. THE CUSTOMER SENT THE PATIENT'S SAMPLES TO BECKMAN COULTER FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562465 ACCESS TOTAL BHCG (5TH IS) SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA BECKMAN COULTER NA 336130

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR