BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3238282 · Received July 19, 2013

    Report

    Report Number
    3002809144-2013-00142
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    PRODUCT EVALUATION WAS COMPLETED IN ORDER TO INVESTIGATE THIS ISSUE. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE USING A FILE KIT OF REAGENT LOT 02312E000. THE TESTING PASSED. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY. THE TICKET SEARCH IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A CORRELATION STUDY LOOKED AT THE PERFORMANCE CHARACTERISTICS OF 6 INTACT PARATHYROID HORMONE ASSAYS, INCLUDING THE ARCHITECT WHICH WAS THE COMPARISON METHOD. FOR METHOD COMPARISON, SERUM AND EDTA PLASMA SAMPLES WERE TESTED BY ALL METHODS. OVERALL THE STUDY FOUND GOOD CORRELATION FOR ALL METHODS, BUT DID INDICATE THERE WAS SIGNIFICANT BIAS BETWEEN METHODS. THE STUDY ALSO CONCLUDED THAT THERE ARE MANY FACTORS THAT POTENTIALLY INFLUENCE VARIABILITY FOR PTH MEASUREMENTS, INCLUDING THE METHOD USED, PTH SOURCE (SYNTHETIC VS ENDOGENOUS), POPULATION EVALUATED, VITAMIN D STATUS, PREANALYTIC VARIABLES SUCH AS SAMPLE MATRIX, AND STORAGE TIME AND TEMPERATURE. THE STUDY ASSESSED SOME OF THESE FACTORS THAT CAN PRODUCE VARIABILITY AND CONFIRMED THAT THERE IS A VARIABILITY BETWEEN PTH ASSAYS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THIS ISSUE. IN ADDITION, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED. THE PRODUCT PACKAGING RECOMMENDS THAT EACH LAB ESTABLISH ITS OWN RANGES. REVIEW OF PRODUCT LABELING INDICATES THAT A POSITIVE BIAS HAS BEEN OBSERVED WHEN COMPARING METHODS. TESTING AND QUALITY DATA REVIEW INDICATES THAT THE ASSAY IS PERFORMING ACCEPTABLY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT IPTH REAGENTS ARE PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE MORE PATIENT SAMPLE GENERATED A HIGHER THAN EXPECTED RESULT OF 91.8 PG/ML FOR THE IPTH ASSAY. THE CUSTOMER SUSPECTED THE RESULT AND SENT THE SAMPLE OUT TO A REFERENCE LAB FOR RETESTING. THE CUSTOMERS NORMAL RANGE IS 15-65 PG/ML AND THE CUSTOMER IS EXPECTING THE PATIENT RESULTS TO BE WITHIN THE NORMAL RANGE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337362 ARCHITECT IPTH CEW ABBOTT GERMANY 02312E000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR 01L86-01, SN (B)(4)| ARCHITECT I1000SR 01L86-01, SN (B)(4)