BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSIL SYNTHASIL

    MDR report key: 20150232 · Received September 5, 2024

    Report

    Report Number
    1217183-2024-00005
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 28, 2024
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GFO
    UDI-DI
    08426950078920
    PMA / PMN Number
    K060688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE INSTRUMENT "SAMPLE DETAIL" REPORTS FOR THE 32 PATIENT SAMPLES CONFIRMS THE ORIGINAL AND REPEAT RESULTS. ALL RESULTS WERE FLAGGED BY THE INSTRUMENT EITHER WITH "MT 5600 MAINTENANCE OVERDUE" OR AS FAILED. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT VERIFICATION. THE CUSTOMER REQUESTED THAT WE REPORT THIS INCIDENT. HOWEVER, THE COMPLAINT IS STILL UNDER INVESTIGATION AND ITS REPORTABILITY HAS YET TO BE DETERMINED. A FOLLOW-UP FILING WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    A CUSTOMER SUBMITTED A COMPLAINT ON HEMOSIL SYNTHASIL LOT N0532089 ON AUGUST 07, 2024 INDICATING THERE WERE 32 PATIENT RESULTS REPORTED INCORRECTLY ON ACL TOP 550 CTS SN (B)(6). CONTROLS WERE RUN AT 07:30 AND RECOVERED WITHIN ACCEPTANCE RANGE FOR THE APPT ASSAY. WHEN THE CONTROLS WERE RUN AGAIN AT 15:00, RESULTS WERE OUTSIDE OF THE ACCEPTANCE RANGE. THE USER REPLACED THE SYNTHASIL AND CACL2 REAGENTS AND CONTROLS CAME BACK INTO RANGE. ALL THE PATIENTS WERE RUN DURING THAT TIME FRAME WERE RERUN AND 32 CORRECTED REPORTS WERE ISSUED. THERE IS NO KNOWN PATIENT IMPACT. COMPLAINT INVESTIGATION INCLUDED THE REVIEW OF THE GENERAL LOG FOR 8/6/24 FROM 07:00 TO 15:30 WHICH SHOWED NO ERRORS OR WARNINGS THAT WOULD HAVE CONTRIBUTED TO THE ERRONEOUS RESULTS. THE SERVICE REPORT NOTES INCLUDED "HUMIDITY LEVEL IN THE LAB IS HIGH, THE REAGENT AREA HAS LOTS OF CONDENSATION SOME OF WHICH WAS ON BOTTLES AND THE SPLASH GUARD." UPON FURTHER DISCUSSION WITH THE FIELD SERVICE ENGINEER (FSE), IT WAS DISCOVERED THAT THE LABORATORY'S HVAC SYSTEM WAS NOT FUNCTIONING AS EXPECTED AT THE TIME. THE WEATHER AT THAT TIME ACCORDING TO WEATHER UNDERGROUND DATA ADJACENT TO THE (B)(6) HOSPITAL ON (B)(6) 2024 LIST A DAILY HIGH OF 95°F (OVER 90°F FROM 11:30 TO 14:30) WITH AN AVERAGE HUMIDITY BETWEEN 85 AND 87%. THIS, IN ADDITION TO THE HVAC SYSTEM STATUS PROVIDED BY THE FSE, SUGGESTS THAT THE CONDITIONS IN THE LABORATORY WERE LIKELY OUTSIDE THE ACL TOP'S ENVIRONMENTAL CONDITION SPECIFICATIONS. THE ACL TOP FAMILY 50-SERIES OPERATOR'S MANUAL STATES UNDER SECTION ENVIRONMENTAL CONDITIONS: THE INSTRUMENT FUNCTIONS CORRECTLY IN AN AMBIENT TEMPERATURE OF 15°C TO 32°C (50°F TO 89°F) WITH A RELATIVE HUMIDITY OF 15% TO 85% (NON-CONDENSING). ALTHOUGH, THE ROOT CAUSE OF THE ERRONEOUS RESULTS WAS NOT IDENTIFIED, ENVIRONMENTAL CONDITIONS MAY BE A CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL (PART NO. 0020006800, LOT NO. N0532089), INDICATING THAT THERE WERE 32 INCORRECT APTT PATIENT RESULTS REPORTED BY THE ACL TOP 550 CTS (SERIAL NO. 19071186). QUALITY CONTROL RESULTS PRIOR TO PATIENT TESTING WERE WITHIN ACCEPTANCE CRITERIA. HOWEVER, WHEN QUALITY CONTROLS WERE RUN AFTER PATIENT TESTING, THE RESULTS WERE OUTSIDE OF ACCEPTANCE CRITERIA. THE USER REPLACED THE REAGENTS, AND THEN QUALITY CONTROLS CAME BACK INTO RANGE. THE PATIENTS RUN DURING THE TIME PERIOD WERE RERUN AND 32 CORRECTED PATIENT REPORTS WERE ISSUED. THERE IS NO KNOWN PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887390 HEMOSIL SYNTHASIL ACTIVATED PARTIAL THROMBOPLASTIN GFO INSTRUMENTATION LABORATORY CO. N0532089 08426950078920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown