BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCHITECT TOTAL B-HCG REAGENTS

    MDR report key: 3800797 · Received May 8, 2014

    Report

    Report Number
    3005094123-2014-00012
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    August 31, 2013
    Report Date
    April 11, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW WAS COMPLETED ON ALL COMPLAINTS ASSOCIATED WITH ARCHITECT TOTAL B-HCG (LN 7K78) AND ARCHITECT TOTAL B-HCG REAGENT LOT 26903UI00. NO ATYPICAL COMPLAINT ACTIVITY OR ADVERSE TRENDS FOR THIS PRODUCT WAS IDENTIFIED. LOT 26903UI00 WAS USED TO TEST UK NEQAS PROFICIENCY SAMPLES. A REVIEW OF THIS TESTING CONCLUDED THAT THE ASSAY ACCURATELY RECOVERED DIFFERENT LEVELS OF ANALYTE IN EXTERNAL QUALITY SAMPLES THUS CONCLUDING THE ASSAY PERFORMS ACCEPTABLY. NO TESTING OF A RETAINED KIT COULD BE PERFORMED AS THE MATERIAL WAS EXPIRED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER REPORTED A CASE OF A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT OF LESS THAN 1.20 MIU/ML OBTAINED (B)(6) 2013 FOR ONE (B)(6) FEMALE PATIENT. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2013 WITH CHEST PAINS AND PAINFUL BREATHING. TESTING REVEALED CRITICALLY LOW PLATELET COUNTS AND THE PATIENT WAS DIAGNOSED WITH IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP). SEVERAL TESTS WERE PERFORMED OVER THE FOLLOWING 7 DAYS, INCLUDING B-HCG TESTING. NO ADDITIONAL PREGNANCY DIAGNOSTICS WERE RUN AT THE HOSPITAL. THE PATIENT WAS THEN SENT TO (B)(6) WHERE A CASSETTE PREGNANCY TEST WAS PERFORMED WITH A NEGATIVE RESULT. THE PATIENT SUBSEQUENTLY DIED (B)(6) 2013, AND THE CUSTOMER COMMUNICATED THAT THE CAUSE OF DEATH WAS A RUPTURED ECTOPIC PREGNANCY. NO AUTOPSY REPORT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279320 ARCHITECT TOTAL B-HCG REAGENTS B-HCG DHA A.I.D.D LONGFORD 26903UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death ARCHITECT I2000SR ANALYZER| LN 03M74-01 SN (B)(4)