BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8790011 · Received July 15, 2019

    Report

    Report Number
    8031673-2019-00247
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 20, 2019
    Report Date
    September 20, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE CUSTOMER PERFORMED A FOUR (4) SAMPLE CORRELATION STUDY BETWEEN QUEST AND TOSOH AIA-360 FOR IPTH. THE REFERENCE RANGES/METHODOLOGY ARE DIFFERENT, THEREFORE THE ACTUAL NUMBERS ARE LESS IMPORTANT THAN IF THE SAMPLES ARE DIAGNOSTICALLY THE SAME. 3 OF THE 4 SAMPLES SHOWED NO DIAGNOSTIC DIFFERENCE. ONE SHOWS A HIGH NORMAL WITH THE AIA-360 AND A HIGH RESULT FOR QUEST. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER TROUBLESHOOT THE REPORTED EVENT. FIELD SERVICE ENGINEERING (FSE) WAS AT THE CUSTOMER'S SITE TO RESOLVE REPORTED EVENT. FSE REVIEWED THE BIO-RAD (BR) AND MAC IPTH CONTROLS AND CONFIRMED ALL RESULTS WERE WITHIN PUBLISHED RANGES AND CLOSE TO THE MEAN VALUES. FSE REVIEWED IPTH CALIBRATION AND THE PRECISION OF CALIBRATOR POINTS WAS OKAY AND WITHIN 10% OF ONE ANOTHER, QC WAS GOOD AND STABLE ON EIGHT (8) OTHER ASSAYS, EXCEPT FOR LEVEL 1 FOR THE TESTOSTERONE (TES). FSE DETERMINE THE INSTRUMENT IS FUNCTIONING PROPERLY, AND NO FURTHER DIAGNOSES IS NECESSARY ON THE INSTRUMENT. FSE RECOMMENDED THAT THE CUSTOMER AGE WASH 48 HOURS BEFORE CALIBRATING OR RUNNING QC FOR TES. FSE ALSO ADVISED THE CUSTOMER TO RECALIBRATE IPTH AND DELETE THE LOWER RATES ON THE 6 CALIBRATOR POINTS TO HELP RAISE THE IPTH CONCENTRATION RESULTS IN ORDER TO MORE LIKELY COMPLY WITH THE API MATERIALS FOR IPTH, WHICH SHOULD STILL BE WELL WITHIN NORMAL BR AND MAC QC RANGES ALSO. CUSTOMER AGREED TO TRY THIS AND CORRELATE WITH QUEST AGAIN AND IF RESULTS WERE ELEVATED AND BETTER MATCHED, THEN RE-ORDER AND RE-SUBMIT THE API MATERIAL FOR IPTH. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS RELATED TO THE API SAMPLE.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) AND IPTH LOT I915219 THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE ST AIA-PACK INTACT PTH APPLICATION ANALYTE MANUAL STATES: LIMITATIONS OF THE PROCEDURE: 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. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF GOAT POLYCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-GOAT ANTIBODIES. SUCH SPECIMENS MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR INTACT PARATHYROID HORMONE. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. SPECIMENS FROM PATIENTS TAKING MEDICINES AND/OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS PENDING; INVESTIGATION STILL IN PROGRESS

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY FAILED 2 OUT OF 3 INTACT PARATHYROID HORMONE (IPTH) SAMPLES FOR AMERICAN PROFICIENCY INSTITUTE (API) SURVEY STUDY ON THE AIA-360 INSTRUMENT. THE TOSOH QA LAB PASSED ALL IPTH RESULTS. THE IPTH LOT WAS I915219. THE CUSTOMER'S API RESULTS FOR IPTH WERE AS FOLLOWS: (B)(6). THE CUSTOMER CONFIRMED QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE AT THE TIME THE PROFICIENCY TESTING WAS RAN, RULING OUT INSTRUMENT FAILURE OR MALFUNCTION. THE CUSTOMER INDICATED THEY DO NOT WANT TO PURCHASE A SECOND SET OF API SAMPLES TO RUN. TECHNICAL SUPPORT SPECIALIST (TSS) RECOMMENDED THE CUSTOMER RUN A CORRELATION STUDY AND CALL BACK WITH THE RESULTS. THE CUSTOMER IS YET TO PERFORM THE CORRELATION STUDY; THEREFORE, RESULT IS STILL PENDING FROM THE CUSTOMER. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT SURVEY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582285 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1