BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 3801284 · Received May 8, 2014

    Report

    Report Number
    3005094123-2014-00013
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    February 26, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT REFERENCES REPORT NUMBER 3008344661-2014-00020 WHICH WAS FILED WITH THE INCORRECT MANUFACTURER NAME, CITY AND STATE . THIS REPORT IS BEING SUBMITTED IN ORDER TO LIST THE CORRECT MANUFACTURER NAME, CITY AND STATE. (B)(4). PRODUCT EVALUATION WAS COMPLETED IN ORDER TO INVESTIGATE THIS ISSUE. A REVIEW OF COMPLAINTS ASSOCIATED WITH THE ARCHITECT TOTAL B HCG ASSAY WAS PERFORMED AND DID NOT IDENTIFY ANY NON-STATISTICAL TRENDS OR ATYPICAL COMPLAINT ACTIVITY FOR THE ASSAY. ACCURACY TESTING WAS PERFORMED AND ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING THIS TESTING DEMONSTRATING THE ABILITY OF THE ARCHITECT TOTAL B HCG ASSAY TO PROVIDE ACCURATE RESULTS IN A PORTION OF THE DYNAMIC RANGE. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY OR MALFUNCTION WERE IDENTIFIED TO BE RELATED TO THIS ISSUE. THE CUSTOMER WAS REFERRED TO THE ARCHITECT TOTAL B HCG ASSAY INSERT, WHICH INDICATED THAT SPECIMENS WITH B HCG LEVELS GREATER THAN 5.00 MIU/ML AND LESS THAN 25.00 MIU/ML WILL BE REPORTED WITH CONCENTRATIONS ONLY. NO CLINICAL INTERPRETATION WILL BE REPORTED FOR THESE RESULTS. THE INSERT ALSO MENTIONED THAT ELEVATED HCG LEVELS HAVE BEEN ASSOCIATED WITH SOME PATHOLOGICAL CONDITIONS (E.G., TROPHOBLASTIC AND NON-TROPHOBLASTIC NEOPLASMS) BUT THE RESULTS OF THIS TEST SHOULD NOT BE USED IN THE DIAGNOSIS OF THESE ABNORMAL STATES. THE INSERT ALSO INDICATED THAT THE RESULTS FROM THIS TEST SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. IF THE HCG LEVEL IS INCONSISTENT WITH, OR UNSUPPORTED BY, CLINICAL EVIDENCE, THE RESULTS SHOULD BE CONFIRMED BY AN ALTERNATE HCG METHOD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT WITH AN ARCHITECT B-HCG RESULT OF 20 MIU/ML IN (B)(6) 2013, HAD A TOTAL OF 17 DIFFERENT HCGS OVER THE NEXT TWO MONTHS WITH RESULTS VARYING FROM 13 TO 20 MIU/ML. SHE WAS THEN UNNECESSARILY TREATED WITH METHOTREXATE FOR A PRESUMED PLACENTAL NEOPLASM. THE PATIENT WAS CLINICALLY NEGATIVE REGARDING THE PLACENTAL NEOPLASM. THE ARCHITECT B-HCG RESULTS WERE INTERPRETED AS POSITIVE AND THEREFORE, THE PATIENT WAS TREATED. THE PATIENT TESTED NEGATIVE FOR B-HCG WHEN TESTED WITH OTHER MANUFACTURERS (ROCHE, BECKMAN, AND SIEMENS). NO FURTHER IMPACT TO PATIENT HEALTH WAS REPORTED AS A RESULT OF THE METHOTREXATE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279536 ARCHITECT TOTAL B-HCG B-HCG DHA A.I.D.D LONGFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARCHITECT I2000SR 03M74-02, SN (B)(4)