BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3453318 · Received November 6, 2013

    Report

    Report Number
    3002809144-2013-00179
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 17, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (SUSPECT MEDICAL DEVICE, LOT) DOCUMENTED THE INCORRECT LOT NUMBER. THE CORRECT LOT NUMBER SHOULD BE 01113C000.

    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08K25-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K25-27. (B)(4).

    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 REPORTS A FALSELY ELEVATED ARCHITECT IPTH ASSAY RESULT FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2013 = 81.8 PG/ML; (B)(6) 2013 = 140 PG/ML; (B)(6) 2013 = 232 PG/ML; AND, (B)(6) 2013 = 69 PG/ML (NON-ABBOTT METHODOLOGY). THE CUSTOMER USES A REFERENCE RANGE OF 15.0 TO 65.0 PG/ML. THE CUSTOMER STATES THAT THE NON-ABBOTT RESULTS ARE MORE CONSISTENT WITH THE PATIENT CLINICAL CONDITION. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573206 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 01113C000

    Patients

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