BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 17243166 · Received June 30, 2023

    Report

    Report Number
    1225673-2023-00004
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 12, 2023
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A REPRESENTATIVE FROM THE FACILITY PROVIDED ADDITIONAL INFORMATION ON THE POTENTIAL PATIENT IMPACT. THE FACILITY STATED THAT AFTER A REVIEW OF THE DATA, THE INVESTIGATION CONCLUDED THERE WAS NO NEGATIVE IMPACT TO PATIENT CARE AS A RESULT OF THE INITIAL RESULT WITH THE ">" BEING REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS) INSTEAD OF THE DILUTED RESULTS. THE RESULTS VERIFIED WITH A ">" VALUE WERE CORRECTED ONCE THE DILUTION RESULTS WERE COMPLETED. BASED ON ADDITIONAL PATIENT IMPACT INFORMATION PROVIDED BY THE FACILITY, TWO DATA VALUES HAVE BEEN UPDATED IN SECTION H6. FIRST, THE HEALTH EFFECT - CLINICAL CODE HAS BEEN UPDATED TO 4582: NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. SECOND, THE HEALTH EFFECT - IMPACT CODE HAS BEEN UPDATED TO 2199 - NO HEALTH CONSEQUENCES OR IMPACT. INFORMATION FROM ORIGINAL REPORT: A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS LLC (MANUFACTURER), ABBOTT LABORATORIES (DISTRIBUTOR), AND LAFAYETTE GENERAL MEDICAL CENTER (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT WHEN CERTAIN IMMUNOASSAY TESTS SUCH AS CRP, CK, AND BHCG HAVE RESULTS ABOVE LINEARITY AND THEREFORE REQUIRE DILUTION, ONLY THE INITIAL RESULT WITH THE ">" RESULT IS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS) INSTEAD OF THE DILUTED RESULTS. DURING REVIEW OF A FORMAT UPPER LIMIT REPORTING RULE (USER FACILITY PROGRAMMED LOGIC), IT WAS DETERMINED THAT THE UPPER LIMIT FORMATTING CLINICAL REPORTABLE RANGE (CRR) TABLE (REPRESENTING THE HIGHEST VALUE THAT AN INSTRUMENT CAN REPORT AS A RESULT WITH DILUTION) WAS NOT DEFINED CORRECTLY. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER MEDICAL DEVICE. THE ROOT CAUSE IS DUE TO INCORRECT VALUES CONFIGURED IN THE UPPER LIMIT REPORTING RULE. THE FACILITY HAS SINCE CORRECTED THE RULE. A PATIENT IMPACT STATEMENT HAS NOT YET BEEN RECEIVED BY DATA INNOVATIONS AND THEREFORE PATIENT IMPACT HAS BEEN UNABLE TO BE DETERMINED AT THIS TIME. AN INVESTIGATION TO DETERMINE POTENTIAL PATIENT IMPACT IS ONGOING AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS LLC (MANUFACTURER), ABBOTT LABORATORIES (DISTRIBUTOR), AND LAFAYETTE GENERAL MEDICAL CENTER (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT WHEN CERTAIN IMMUNOASSAY TESTS SUCH AS CRP, CK, AND BHCG HAVE RESULTS ABOVE LINEARITY AND THEREFORE REQUIRE DILUTION, ONLY THE INITIAL RESULT WITH THE ">" RESULT IS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS) INSTEAD OF THE DILUTED RESULTS. DURING REVIEW OF A FORMAT UPPER LIMIT REPORTING RULE (USER FACILITY PROGRAMMED LOGIC), IT WAS DETERMINED THAT THE UPPER LIMIT FORMATTING CLINICAL REPORTABLE RANGE (CRR) TABLE (REPRESENTING THE HIGHEST VALUE THAT AN INSTRUMENT CAN REPORT AS A RESULT WITH DILUTION) WAS NOT DEFINED CORRECTLY. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER MEDICAL DEVICE. THE ROOT CAUSE IS DUE TO INCORRECT VALUES CONFIGURED IN THE UPPER LIMIT REPORTING RULE. THE FACILITY HAS SINCE CORRECTED THE RULE. A PATIENT IMPACT STATEMENT HAS NOT YET BEEN RECEIVED BY DATA INNOVATIONS AND THEREFORE PATIENT IMPACT HAS BEEN UNABLE TO BE DETERMINED AT THIS TIME. AN INVESTIGATION TO DETERMINE POTENTIAL PATIENT IMPACT IS ONGOING AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE RESELLER REPORTED ON 05 JUN 2023 THAT WHEN CERTAIN IMMUNOASSAY TESTS SUCH AS CRP, CK, AND BHCG HAVE RESULTS ABOVE LINEARITY AND THEREFORE REQUIRE DILUTION, ONLY THE INITIAL RESULT WITH THE ">" RESULT IS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS) INSTEAD OF THE DILUTED RESULTS.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE RESELLER REPORTED ON 05 JUN 2023 THAT WHEN CERTAIN IMMUNOASSAY TESTS SUCH AS CRP, CK, AND BHCG HAVE RESULTS ABOVE LINEARITY AND THEREFORE REQUIRE DILUTION, ONLY THE INITIAL RESULT WITH THE ">" RESULT IS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS) INSTEAD OF THE DILUTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344016 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.17.30

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown