BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2133091 · Received June 18, 2011

    Report

    Report Number
    3002809144-2011-00503
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRENDING DID NOT IDENTIFY ANY RELATED ADVERSE TRENDS. IN ADDITION, THERE IS NO UNUSUAL COMPLAINT ACTIVITY FOR REAGENT LOT 00610K000. ACCURACY TESTING WAS COMPLETED ON REAGENT LOT 00610K000 AND PASSED ALL VALIDITY AND ACCEPTANCE CRITERIA. A STUDY THAT WAS PERFORMED TO EVALUATE THE PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE (PTH) ASSAYS, INCLUDING THE ARCHITECT IPTH ASSAY WAS REVIEWED. BASED ON THIS DATA THE ARCHITECT IPTH ASSAY SHOWS A (B)(6) BIAS OF APPROXIMATELY 30% TO THE ROCHE E170 IPTH ASSAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT IPTH REAGENTS ARE PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PHYSICIAN NOTED THAT A NUMBER OF PATIENTS HAVE ELEVATED IPTH RESULTS ON THE ARCHITECT I2000SR ANALYZER (NORMAL RANGE 9 - 73 PG/ML) BUT ARE WITHIN NORMAL RANGE ON THE ROCHE METHOD (NORMAL RANGE 15 - 65 PG/ML). A COMPARISON STUDY WAS CONDUCTED BETWEEN THE TWO METHODS. A PATIENT SAMPLE GENERATED AN ELEVATED IPTH RESULT OF 78 PG/ML ON THE ARCHITECT BUT HAD A NORMAL VALUE OF 48 PG/ML ON THE ROCHE METHOD. THE ARCHITECT RESULT HAD BEEN REPORTED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IPTH CEW ABBOTT GERMANY 00610K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST # 3M74-01 SERIAL # (B)(4)| ARCHITECT I2000SR LIST #3M74-01| SERIAL # (B)(4)