BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG II ST AIA-PACK

    MDR report key: 12972943 · Received December 9, 2021

    Report

    Report Number
    9612316-2021-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    October 26, 2021
    Report Date
    April 26, 2022
    Manufacturer
    TOSOH AIA, INC.
    Product Code
    JLX
    UDI-DI
    14560189213392
    PMA / PMN Number
    K143144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REPORTED RESULTS, THE CUSTOMER WAS INSTRUCTED TO RUN A PRECISION RUN ON THREE PATIENT SAMPLES TO VERIFY THE PROPER SAMPLING OF THE AIA-360 ANALYZER. THE TOSOH REGIONAL SERVICE MANAGER PROVIDED DIRECTION AND ADDITIONAL KITS WERE PROVIDE TO THE CUSTOMER TO COMPLETE THE PRECISION STUDIES OVER THE RANGE OF THE ASSAY. THE RESULTS OF THE TESTING CONFIRMED THE AIA-360 ANALYZER WAS PERFORMING AS EXPECTED. NO FURTHER ACTION REQUIRED BY TOSOH. BASED ON THE INFORMATION PROVIDED THE MOST LIKELY CAUSE WAS EITHER A SAMPLE INTEGRITY ISSUE OR A SAMPLE MISLABEL.

    Additional Manufacturer Narrative · 0

    A COMPLAINT, LOT AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM INSTALLATION DATE TO AWARE DATE FOR PROG II TEST CUP LOT NUMBER B11C778. THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE ST AIA-PACK PROGII ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: SPECIMEN COLLECTION AND HANDLING. SERUM OR HEPARINIZED PLASMA IS REQUIRED FOR THE ASSAY. EDTA AND CITRATED PLASMA SHOULD NOT BE USED. WHEN USING SERUM, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITHOUT ADDITIVES. STORE AT 18 - 25 °C UNTIL A CLOT HAS FORMED (USUALLY 15-45 MINUTES), THEN CENTRIFUGE TO OBTAIN THE SERUM SPECIMEN FOR ASSAY. WHEN USING HEPARINIZED PLASMA, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITH DESIGNATED ADDITIVE. CENTRIFUGE AND SEPARATE PLASMA FROM THE PACKED CELLS AS SOON AS POSSIBLE. INADEQUATE CENTRIFUGATION OR THE PRESENCE OF FIBRIN OR PARTICULATE MATTER IN THE SAMPLE MAY CAUSE AN ERRONEOUS RESULT. SAMPLES CONTAINING INHIBITORS OF ALKALINE PHOSPHATASE MAY CAUSE ERRONEOUS RESULTS. INSPECT ALL SAMPLES FOR AIR BUBBLES AND FOAMING. REMOVE ANY AIR BUBBLES PRIOR TO ASSAY. SPECIMEN TYPES SHOULD NOT BE USED INTERCHANGEABLY DURING SERIAL MONITORING OF AN INDIVIDUAL PATIENT. MEASURED CONCENTRATIONS MAY VARY SLIGHTLY BETWEEN SAMPLE TYPES IN CERTAIN PATIENTS. SAMPLES MAY BE STORED AT 2 - 8 °C FOR UP TO 7 DAYS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 7 DAYS, THE SAMPLE SHOULD BE STORED FROZEN AT -20 °C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. TURBID SERUM SAMPLES OR SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE CENTRIFUGED PRIOR TO TESTING. PRIOR TO ASSAY, BRING FROZEN SAMPLES TO 18 - 25 °C SLOWLY AND MIX GENTLY. THE SAMPLE REQUIRED FOR ANALYSIS IS 75 L. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS UNDETERMINED, INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANT RESULT FOR PROGESTERONE II (PROGII) SAMPLE ON THE AIA-360 ANALYZER. THE RESULT WAS 3.55NG/ML AND THE PHYSICIAN QUESTIONED THE RESULT; THE PATIENT SAMPLE WAS SENT TO A REFERENCE LAB FOR COMPARISON AND RESULT WAS 1.5NG/ML. THE SPECIMEN WAS REPEATED ON THE AIA-360 AND RESULT WAS STILL CONSISTENT AROUND 3.0NG/ML. A NEW SPECIMEN WAS DRAWN THE NEXT DAY AND THE AIA-360 RESULT WAS 1.8NG/ML. THE TECHNICAL SUPPORT SPECIALIST (TSS) EXPLAINED THERE IS A DIFFERENCE IN MANUFACTURER'S RANGES AND INTERPRETATION. REFERENCE LAB RANGES ARE: FOLLICULAR - 0.1-0.9; LUTEAL - 1.8-23.9; OVULATION - 0.1-12.0. TOSOH'S RANGES ARE: FOLLICULAR - </= 2.05; LUTEAL - </= 22.65; OVULATION - </= 19.56. TSS CONFIRMED THE SPECIMEN WAS DRAWN IN AN SST TUBE, CLOTTED FOR 30 MIN AND SPUN 5 - 10 MIN. THE SPECIMEN WAS NOT POURED OFF. THE CUSTOMER CONFIRMED QUALITY CONTROL AND CALIBRATION RUN RESULTS WERE ALL IN RANGE. TSS SENT PROGESTERONE III (PROGIII) REAGENTS TO THE CUSTOMER TO EVALUATE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE TO FURTHER INVESTIGATION. 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
    1871699 PROG II ST AIA-PACK RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE JLX TOSOH AIA, INC. PROG II ST AIA-PACK B11C778 14560189213392

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown