BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 1930512 · Received December 16, 2010

    Report

    Report Number
    1628664-2010-00487
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. WITH A UNIQUE COMBINATION OF INSTRUMENT AND REAGENT CONDITIONS THERE IS A POTENTIAL FOR SAMPLE CARRYOVER WHICH CAN RESULT IN FALSELY ELEVATED B-HCG CONCENTRATIONS ON THE ARCHITECT I1000SR SYSTEM. NEGATIVE SAMPLES HAVE RETURNED BOTH POSITIVE AND GREY ZONE B-HCG RESULTS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASSESSED PRIOR TO THE NEGATIVE SAMPLE WITH ARCHITECT TOTAL B-HCG (LIST NUMBER 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS CHANGED FROM THE (B)(4). MFR # 3005094123-2011-00588 HAS BEEN SUBMITTED TO ADDRESS THIS ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT. THE FSE INSPECTED THE ANALYZER AND NOTICED THE PROBE WAS NOT TIGHTENED. AS A PREVENTATIVE ACTION THE FSE REPLACED AND CALIBRATED THE PROBE. IN ADDITION THE SYRINGE AND WASH ZONE 2 VALVES WERE REPLACED. THE PROBABLE CAUSE OF THE ISSUE WAS THE PROBE NOT BEING PROPERLY TIGHTENED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT B-HCG PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE OF ERRATIC RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT (B)(4) ANALYZER GENERATED A FALSE POSITIVE B-HCG RESULT OF 90.54 MIU/ML WHICH WAS REPORTED. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT, <1.20 MIU/ML WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL B-HCG AUTOMATED IMMUNOASSAY ANALYZER DHA A.I.D.D LONGFORD 89908JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT B-HCG REAGENT, 7K78-25 LOT 89908JN00| ARCHITECT B-HCG REAGENT, 7K78-25 LOT 89908JN00| ARCHITECT B-HCG REAGENT, 7K78-25 LOT 89908JN00| ARCH I1000SR LN 01L86-01 (B)(4)