BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 1832591 · Received September 13, 2010

    Report

    Report Number
    1628664-2010-00326
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT CUSTOMER SUPPORT SPECIALIST (CSS) VISITED THE CUSTOMER SITE AND REPROCESSED THE SUSPECT PATIENT SAMPLE FIVE TIMES, WHERE THE PRECISION RESULTS WERE WITHIN THE ACCEPTABLE RANGES. AS A PRECAUTION, THE CSS REPLACED THE PROBE AND WASH CUP. HE PROCEEDED TO PERFORM A PRECISION RUN, WHERE THE RESULTS WERE WITHIN RANGE. THE RESULTS FOR THIS SAMPLE WERE < 1.2, < 1.2, 11.6, 5.05, 3.31, < 1.2, < 1.2, < 1.2, AND < 1.2 MIU/ML. SOME TINY BUBBLES WERE OBSERVED ON THE INLET TUBING FROM THE BUFFER RESERVOIR TO THE PUMP. THE EVALUATION FAILED TO DETERMINE A SINGLE DEFINITIVE CAUSE OF THE CUSTOMER'S CURRENT ISSUE. REVIEW OF DOCUMENTATION IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. A DEFICIENCY WAS IDENTIFIED, POSSIBLY DUE TO SAMPLE OR REAGENT CARRY-OVER. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE FOLLOWING DISCREPANT RESULTS WERE GENERATED OVER A TWO HOUR PERIOD ON ONE PATIENT SAMPLE WITH THE ARCHITECT TOTAL B-HCG ASSAY (TAKEN FROM AN ATTACHED INSTRUMENT PRINTOUT): RUN #: 1, RESULT (MIU/ML): 8.54. RUN #: 2, RESULT (MIU/ML): 2.38 NEGATIVE; RUN #: 3, RESULT (MIU/ML): < 7000.00, < FLAG, 476 MIU/ML (HANDWRITTEN), POSITIVE. RUN #: 4, RESULT (MIU/ML): < 1.20, < FLAG, 0.88 (HANDWRITTEN), NEGATIVE. RUN #: 5, RESULT (MIU/ML): <1.20, < FLAG, 0.70 (HANDWRITTEN), NEGATIVE. RUN #: 6, RESULT (MIU/ML): <1.20, < FLAG, 0.75 (HANDWRITTEN), NEGATIVE. RUN #: 7, RESULT (MIU/ML): <7000.00, < FLAG, 1.33 (HANDWRITTEN), NEGATIVE. RUN #: 8, 19.05. RUN #: 9, 17.96. RUN #: 10, 8.14. AN ABBOTT CUSTOMER SERVICE SPECIALIST (CSS) VISITED THE CUSTOMER SITE AND COULD NOT RE-CREATE THIS ISSUE. ALL PRECISION RUNS PERFORMED BY THE CSS MET SPECIFICATIONS. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NOTE: "<" FLAG INDICATES THE RESULT SHOULD BE REVIEWED AS IT IS OUTSIDE THE DYNAMIC OR LINEAR RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER DHA ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARCH I1000SR LN 01L86-01 SN: (B)(6).| ARCH TOTAL B-HCG LN: 7K78-20.| ARCH TOTAL B-HCG LN: 7K78-20.| ARCH TOTAL B-HCG LN: 7K78.| ARCH TOTAL B-HCG LN: 7K78| ARCH TOTAL B-HCG LN: 7K78-20| ARCH TOTAL B-HCG LN: 7K78-20