BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 3142323 · Received June 3, 2013

    Report

    Report Number
    3005094123-2013-00034
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 17, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT PROBLEM CODE: NO CONSEQUENCES OR IMPACT TO PATIENT, (B)(4).

    Additional Manufacturer Narrative · 1

    RETURNS WERE NOT AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. FILE SAMPLE TESTING WAS NOT PERFORMED AS A REVIEW OF THE ARCHITECT TOTAL B-HCG ASSAY, LIST NUMBER 07K78, REAGENT LOT NUMBER 23927JN00, DID NOT INDICATE ATYPICAL COMPLAINT ACTIVITY FOR THE REAGENT IN QUESTION. THIS IS THE FIRST COMPLAINT RECEIVED IN RELATION TO THIS LOT NUMBER. A REVIEW OF THE INSTRUMENT LOGS FROM THE CUSTOMER SITE INDICATES THAT THIS LOT WAS USED A TOTAL OF 1290 TIMES AND PROVIDED RESULTS INDICATIVE OF THE REAGENT AND INSTRUMENT CAPABILITY TO ACCURATELY PROVIDE RESULTS CONSISTENT WITH INDIVIDUAL PATIENT CLINICAL CONDITIONS. THE ARCHITECT TOTAL B-HCG ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATION MANUAL PROVIDE INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE DATA REVIEWED FROM THE CUSTOMER SITE IN CONJUNCTION WITH THE RESULTS OF THE CURRENT EVALUATION DEMONSTRATE THAT THE ARCHITECT TOTAL B-HCG ASSAY, LIST NUMBER 07K78-30, LOT NUMBER 23927JN00 IS PERFORMING AS EXPECTED. NO ADDITIONAL ISSUES WERE FOUND. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSE POSITIVE ARCHITECT TOTAL B-HCG ASSAY RESULT FOR ONE PATIENT OF 1872.43 MIU/ML. THE RESULT WAS REPORTED FROM THE LAB WITHOUT BEING VERIFIED. THE SAMPLE WAS RETESTED TWO DAYS LATER AND GENERATED A NEGATIVE RESULT (PER ASSAY PACKAGE INSERT THIS IS A VALUE LESS THAN 5.0 MIU/ML). A SECOND SAMPLE WAS DRAWN AND GENERATED A RESULT OF 17 MIU/ML (GRAYZONE). THIS SAMPLE RETESTED AS NEGATIVE. THE SAMPLES WERE COLLECTED IN A SERUM-GEL COLLECTION TUBE. THE CUSTOMER HAS EXPERIENCED SEVERAL ASPIRATION ERRORS ON THE ARCHITECT (B)(4) ANALYZER. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243441 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 23927JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LN:03M74-01SN: (B)(4)| ARCHITECT I2000SR LN:03M74-01SN: (B)(4)