BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH REAGENT

    MDR report key: 1992209 · Received February 15, 2011

    Report

    Report Number
    1415939-2011-00031
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT (ARCHITECT IPTH, LIST #8K25-20) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US (ARCHITECT IPTH, LIST #8K25-27). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). TO INVESTIGATE THE CUSTOMER ISSUE, A REVIEW OF COMPLAINT REPORTS WAS PERFORMED. THIS REVIEW DID NOT IDENTIFY ANY TREND IN COMPLAINT ACTIVITY THAT WOULD INDICATE THAT THE PRODUCT IS PERFORMING CONTRARY TO ITS CLAIMS. IN ADDITION, TESTING WAS PERFORMED TO VERIFY THAT THE LOT NUMBER IN QUESTION IS ABLE TO ACCURATELY DETECT SAMPLES WITH KNOWN CONCENTRATIONS THROUGHOUT THE FULL ASSAY RANGE. TESTING MET ACCEPTANCE CRITERIA. ALL INDIVIDUAL REPLICATES AND GRAND MEANS WERE WITHIN ACCEPTANCE CRITERIA FOR EACH CONCENTRATION LEVEL. BASED ON THE INVESTIGATION PERFORMED, IT WAS DETERMINED THAT THE ARCHITECT INTACT PTH ASSAY IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT IPTH RESULTS WERE GENERATED USING REAGENT LOT 01810D000 ON ARCHITECT I2000SR (B)(4). A RESULT OF 71.7 PG/ML WAS REPORTED ON A PATIENT. THE RESULT WAS QUESTIONED BECAUSE IT WAS HIGHER THAN EXPECTED AND DID NOT FIT THE CLINICAL HISTORY OF THE PATIENT. A RESULT OF 26.9 PG/ML WAS GENERATED FOR THE SAME SAMPLE WHEN SENT OUT FOR TESTING AT A REFERENCE LABORATORY ON A DIFFERENT ARCHITECT I2000SR ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IPTH REAGENT FOR THE DETERMINATION OF INTACT PARATHYROID HORMONE IN SERUM OR PLASMA CEW ABBOTT LABORATORIES 01810D000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 3M74-02 (B)(4)| ARCH I2000SR LN 3M74-02 (B)(4)