BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2970120 · Received February 20, 2013

    Report

    Report Number
    3002809144-2013-00017
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    May 31, 2012
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 IT WAS IDENTIFIED THAT AN ERROR WAS DOCUMENTED IN THE ORIGINAL MANUFACTURE REPORT NUMBER 1415939-2012-00797 WHICH WAS FILED FOR THIS EVENT. THIS REPORT WAS GENERATED TO CORRECT THE MANUFACTURE LOCATION. EVALUATION: FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, A STUDY REVIEW AND A REVIEW OF LABELING. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 01612A000; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE LOT IN QUESTION. A REVIEW THE FOLLOWING STUDY -PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS - SONIA L. LA'ULU, ET AL INDICATED THAT WHILE THE ARCHITECT IPTH ASSAY SHOWED A POSITIVE BIAS, IT CORRELATED WELL AGAINST THE ROCHE MODULE E170. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF ARCHITECT INTACT PTH, LIST 8K25, LOT 01612A000, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED PARATHYROID HORMONE RESULTS WHILE USING THE ARCHITECT IPTH ASSAY (ROUTINE PROTOCOL) COMPARED TO THE RESULTS FROM TWO REFERENCE LABS. THE CUSTOMER INDICATED AN ARCHITECT IPTH RESULT OF 139 PG/ML (THE CUSTOMER REF RANGE USED IS 15 PG/ML - 75 PG/ML). THE SAMPLE WAS SENT TO BE RETESTED AT BOTH (B)(6) AND (B)(6) GENERATING THE FOLLOWING RESULTS: AT (B)(6) = 47 (REF RANGE OF 15 ? 65) AND AT (B)(6) = 53 (REF RANGE OF 15 - 65). THE METHOD USED AT (B)(6) IS ELECTROCHEMILUMINECENT IMMUNOASSAY. THE METHOD USED IS UNKNOWN AT (B)(6). UOM NOT PROVIDED FOR EITHER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73911 ARCHITECT IPTH CEW ABBOTT GERMANY 01612A000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-01, SN (B)(4)