BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3260126 · Received August 1, 2013

    Report

    Report Number
    3002809144-2013-00153
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Removal / Correction Number
    3002809144-02/13/14-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE USING A FILE KIT OF REAGENT LOT 01512K000. THE TESTING PASSED. A STUDY WAS REVIEWED "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS". SONIA L. LA'ULU, AND WILLIAM L. ROBERTS, MD, PHD. AM J CLIN PATHOL 2010;134:930-938, 2010. THIS 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 VARIABILITY BETWEEN PTH ASSAYS. IN CONCLUSION THE STUDY INDICATED THAT STANDARDIZATION EFFORTS ARE WARRANTED AND ASSAY-SPECIFIC DECISION LIMITS ARE REQUIRED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THIS ISSUE. IN ADDITION, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08K25-20, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K25-27. (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ABBOTT HAS CONFIRMED THAT A PERFORMANCE SHIFT IN THE ARCHITECT INTACT PTH ASSAY HAS THE POTENTIAL TO GENERATE FALSELY ELEVATED RESULTS ON PATIENT SAMPLES. A PRODUCT RECALL HAS BEEN ISSUED AND AN INVESTIGATION IS ONGOING TO IDENTIFY THE CAUSE OF THE ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ABBOTT HAS IDENTIFIED INSTABILITY OF THE ARCHITECT INTACT PTH CALIBRATORS TO BE A MAJOR CONTRIBUTOR TO THE OBSERVED INCREASE IN PATIENT SAMPLE VALUES. REDUCED EXPIRATION DATING HAS BEEN IMPLEMENTED TO ADDRESS THE ISSUE. ARCHITECT INTACT PTH CONTROLS ARE MANUFACTURED FROM THE SAME MATRIX MATERIAL AS THE CALIBRATORS. THEREFORE, BOTH ARCHITECT INTACT PTH CALIBRATORS AND CONTROLS WILL HAVE A REDUCED EXPIRATION DATING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT INTACT PTH RESULTS WERE GENERATED FOR SEVEN PATIENTS. THE CUSTOMER CONSIDERS THE RESULTS TO BE FALSELY ELEVATED BECAUSE THE SAMPLES TESTED LOWER AT ANOTHER LABORATORY USING THE ROCHE COBAS METHOD. THE CUSTOMER STATED THAT ROCHE VALUES WERE HALF THE ARCHITECT VALUES AND THAT THE ROCHE VALUES MATCHED THE CLINICAL HISTORY OF THE PATIENTS. THIS EMDR IS FOR PATIENT 5 OF 7 ((B)(6)). ARCHITECT VALUES WERE 106.8 AND 97.6 PG/ML. ROCHE COBAS VALUE WAS HALF (EXACT VALUE NOT PROVIDED). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359826 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 01512K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-02 SN (B)(4)| LIST 03M74-02, SERIAL (B)(4)| ARCHITECT I2000SR ANALYZER| LIST 03M74-02, SERIAL (B)(4)| ARCHITECT I2000SR ANALYZER| LN 03M74-02 SN (B)(4)| ARCHITECT I2000SR ANALYZER