BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 3183032 · Received June 21, 2013

    Report

    Report Number
    3005094123-2013-00036
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 5, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. FROM THE DETAILS IN THE COMPLAINT TICKET BOTH SMP IDS (B)(6) ARE FOR THE SAME PATIENT A REVIEW OF ABBOTTLINK DATA WAS CONDUCTED ON THE CUSTOMERS RESULTS LOG FOR INSTRUMENT (B)(4). REVIEW OF THE DATA DETERMINED THAT THE ARCHITECT TOTAL B-HCG 7K78 REAGENT LOT 23928JN00 IS CAPABLE OF ACCURATELY TESTING PATIENT SAMPLES TO PROVIDE RESULTS CONSISTENT WITH CLINICAL PICTURE AND DOES NOT INDICATE A MALFUNCTION WITH THE DEVICE. A LABELING REVIEW, PERFORMED AS PART OF THIS EVALUATION, IDENTIFIED THAT THERE ARE SUFFICIENT INSTRUCTIONS IN THE PRODUCT LABELING TO ASSIST THE CUSTOMER IN TROUBLESHOOTING THIS ISSUE. A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ARCHITECT B-HCG (LN 7K62) LOT 23928JN00 WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON STATISTICAL TRENDS OR ATYPICAL COMPLAINT ACTIVITY FOR THE ASSAY. A REVIEW OF ALL NON-CONFORMANCE REPORTS AND DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT 23928JN00 AND ALL ASSOCIATED SUB-LOT NUMBERS DEMONSTRATED THAT THERE HAVE BEEN NO KNOWN QUALITY ISSUES IN RELATION TO THIS PRODUCT SINCE THE MANUFACTURE. BASED ON THE EVALUATION RESULTS, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THIS PRODUCT PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT TWO SAMPLES FROM ONE PATIENT GENERATED DISCREPANT RESULTS FOR THE ARCHITECT B-HCG ASSAY. THE FIRST SAMPLE (B)(6) GENERATED RESULTS OF 47.12 AND 22.28 MIU/ML. THE SECOND SAMPLE GENERATED A NEGATIVE RESULT OF < 1.2 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282526 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 23928JN00

    Patients

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