BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS CLINICAL SOLUTION

    MDR report key: 12315262 · Received August 12, 2021

    Report

    Report Number
    3006130047-2021-00001
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ABBOTT INFORMATICS CORPORATION
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER THE RESULT WAS A FALSE POSITIVE AS IT WAS NOT REPEATABLE. THE DONOR INVOLVED DONATED TWICE AFTER THIS ON 17 JULY AND 8 AUG AND WAS TESTED NEGATIVE FOR ALL VIRAL MARKERS. NO FURTHER ACTION REGARDING THE PATIENT IS NEEDED. DURING THE INVESTIGATION THE CUSTOMER TRIED TO REPRODUCE THE PROBLEM ON THEIR QA ENVIRONMENT AND THE EVENT COULD NOT BE REPRODUCED. THE ERROR COULD BE REPRODUCED ON BOTH DEV AND PROD ENVIRONMENTS. THE ISSUE IS LIMITED TO THIS CUSTOMER DUE TO CUSTOMER SPECIFIC CONFIGURATION/CUSTOMIZATION. THE OUT OF THE BOX PRODUCT DOES NOT CONTAIN THESE FEATURES. THE ROOT CAUSE OF THIS ISSUE IS STILL UNDER INVESTIGATION. A FOLLOW UP MDR WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    STARLIMS CLINICAL SOLUTION IS A SOFTWARE SOLUTION FOR MANAGING RESEARCH AND DIAGNOSTIC LABORATORY DATA AND PROCESSES AND IS INTENDED TO BE USED BY TRAINED HEALTHCARE AND RESEARCH LABORATORY PROFESSIONALS. THE APPLICATION PROVIDES SINGLE AND MULTIPLE SITE FACILITIES THE ABILITY TO MANAGE PATIENT AND SAMPLE REGISTRATION, PRE-ANALYTICAL PROCESSING, MANUAL ENTRY OF INFORMATION AND COLLECTION OF DATA FROM IVD ANALYZERS AND/OR NON-DIAGNOSTICS INSTRUMENTS, DATA VALIDATION (TECHNICAL AND/OR CLINICAL) AND RESULT REPORTING. ON 16 JULY 2021 THE CUSTOMER NOTIFIED ABBOTT INFORMATICS THAT THE LABORATORY HAD REPORTED THAT THEY HAD QC SAMPLE DID NOT MEET THE EXPECTED OUTCOME, BUT STARLIMS DIDN'T FAIL THE QC OR THE RUN. THE SAMPLES WERE RELEASED BY THE STARLIMS SYSTEM WHEN THE RESULTS SHOULD HAVE BEEN UNDER REVIEW. A PATIENT RECEIVED BLOOD FROM A DONATION WHERE THE QC HAD FAILED FOR THE FOLLOWING TEST, HCV-NAT-EXT. THIS ENDED WITH A BLOOD TRANSFUSION WITH BLOOD THAT MIGHT NOT HAVE BEEN CORRECTLY TESTED WHICH COULD POSSIBLE TRANSMISSION TRANSFUSION TRANSMISSIBLE DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214203 STARLIMS CLINICAL SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, JQP ABBOTT INFORMATICS CORPORATION CL 10.07

    Patients

    Seq Age Sex Outcome Treatment
    1