BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 6110998 · Received November 17, 2016

    Report

    Report Number
    3002809144-2016-00099
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 6, 2016
    Report Date
    May 12, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST (B)(4), THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AT THE CUSTOMER SITE. HOWEVER, NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED. THE CONCLUSION CODE WAS CHANGED FROM (B)(4).

    Additional Manufacturer Narrative · 1

    NO CUSTOMER RETURN WAS AVAILABLE FOR EVALUATION. THE TREND REVIEW AND LOT SEARCH DID NOT IDENTIFY INCREASED COMPLAINT ACTIVITY. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE USING A FILE KIT OF REAGENT LOT 00916B000. ACCEPTANCE CRITERIA WAS NOT MET, AS REPLICATES OF THE LEVEL 3 CONTROL WERE OUT OF RANGE HIGH WHEN TESTED IN STAT MODE. SWAPOUT TESTING USING A DIFFERENT CONTROL LOT WAS PERFORMED ALONG WITH THE ORIGINAL CONTROL LOT. THE CALIBRATOR LOT USED IN THE FAILING ACCURACY PROTOCOL EXPIRED 06SEP2016, THEREFORE IT COULD NOT BE USED IN THE SWAP OUT TESTING. INSTEAD, ANOTHER CALIBRATOR LOT WAS USED THAT HAD THE SAME BULK MATERIAL. ALL CONTROL REPLICATES MET ACCEPTANCE CRITERIA, THEREFORE A RETEST WAS PERFORMED. ALL REPLICATES MET ACCEPTANCE CRITERIA AND THE TESTING PASSED. THE ORIGINAL FAILURE DOES NOT REPRESENT A NEW COMPLAINT ISSUE AS SUBSEQUENT TESTING PASSED. ADDITIONALLY, THE TECHNOPATH MULTI-CHEM IA PLUS CONTROL PACKAGE INSERT INDICATES THE VALUES ARE PROVIDED ONLY AS GUIDELINES, EACH LABORATORY SHOULD ESTABLISH ITS OWN STATISTICAL LIMITS. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE COMPLAINT ISSUE. BASED ON THE EVALUATION, THE ARCHITECT INTACT PTH ASSAY IS PERFORMING ACCEPTABLY.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED ERRATIC ARCHITECT INTACT PTH RESULTS ON 2 PATIENT SAMPLES COLLECTED DURING PARATHYROID SURGERY. PATIENT 1 SAMPLE TESTED ARCHITECT INTACT PTH OF 819.3, 724.0, 639 (1:3 DILUTION) AND 1523.2 PG/ML (AFTER SITTING A WHILE). THE ACCOUNT REPORTED THE RESULT AS 819 PG/ML. PATIENT 2 SAMPLE TESTED ARCHITECT INTACT PTH OF 383.2, 118.9 AND 448.8 PG/ML (AFTER SITTING A WHILE). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759645 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 00916B000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST (B)(4)| SERIAL (B)(4)