BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8205356 · Received December 29, 2018

    Report

    Report Number
    8031673-2018-05373
    Event Type
    Malfunction
    Date Received
    December 29, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 10NOV2017 THROUGH AWARE DATE 10DEC2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE ST AIA-PACK PARATHYROID HORMONE (PTH) ASSAY SPECIFICATIONS, UNDER LIMITATIONS OF THE PROCEDURE, PAGE 18, STATES THAT FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). USING ST AIA-PACK INTACT PTH, THE HIGHEST CONCENTRATION OF INTACT PARATHYROID HORMONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 2,000 PG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 1.0 PG/ML (ASSAY SENSITIVITY). THE EXACT LINEARITY OF THE ST AIA-PACK INTACT PTH DEPENDS ON THE PARTICULAR LOT OF CALIBRATOR IN USE. ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 2,200 PG/ML, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 2000 PG/ML. ALTHOUGH HEMOLYSIS HAS AN INSIGNIFICANT EFFECT ON THE ASSAY, HEMOLYZED SAMPLES MAY INDICATE MISTREATMENT OF A SPECIMEN PRIOR TO ASSAY AND RESULTS SHOULD BE INTERPRETED WITH CAUTION. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS LIKELY SURVEY SAMPLE-RELATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING THEIR (B)(6) STUDY ON THEIR AIA-900 ANALYZER, FOUR OUT OF FIVE PARATHYROID HORMONE (PTH) RESULTS WERE OUT OF RANGE HIGH. THE CUSTOMER STATED THAT QUALITY CONTROLS (QC) WERE IN RANGE. THE QUALITY CONTROLS WERE NOT TOSOH PTH AND THERE WAS NO PEER GROUP. TECHNICAL SUPPORT SPECIALIST ORDERED ONE SET OF TOSOH PTH QC FOR THE CUSTOMER TO VERIFY WHETHER THE ISSUE WAS QC-RELATED. THE CUSTOMER REPORTED RUNNING THE TOSOH QC, WHICH ALSO RECOVERED WITHIN ACCEPTABLE RANGES, RULING OUT QC BEING THE ISSUE. THE ISSUE MAY BE SURVEY SAMPLE-RELATED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044449 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1