BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-COM V5.0

    MDR report key: 18648106 · Received February 6, 2024

    Report

    Report Number
    9610824-2024-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 6, 2024
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969234417
    PMA / PMN Number
    BK180275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A WRONG RESULT WAS LINKED TO THE WRONG PATIENT DEMOGRAPHICS ON IH-COM ON THE IH-1000 INSTRUMENT. DATAFILES OF THE AFFECTED IH-1000 WERE RETRIEVED BY ONE OF OUR FIELD SERVICE ENGINEERS AND INVESTIGATED. THE PRELIMINARY INVESTIGATION SHOWS THE MISMATCH IS LINKED TO A USER ACTION, WHERE USER PATIENT CXXXXXX, MXXXXXX MRN (B)(6) WAS MERGED WITH GXXXXX, MXXX MRN (B)(6). THIS WAS DONE ON JANUARY 9TH AT 03:09. AFTER THE FIRST CHANGE OF PATIENT DEMOGRAPHICS WAS DONE, THE SAME USER PERFORMED SEVERAL CHANGES ON THIS SAMPLE ID. EVIDENCE WAS FOUND IN THE IH-COM SYSTEM LOG. ONCE THE PATIENT FILES WERE MERGED, THE FOLLOWING SAMPLES WERE LINKED TO THE DEMOGRAPHICS OF PATIENT CXXXXXX, MXXXXXX (MRN (B)(6)), SAMPLES WERE MANUALLY CONFIRMED BY THE CUSTOMER AS CORRECT FOR THIS PATIENT. FOR PATIENT GXXXXX, MXXX MRN (B)(6), THE PATIENT HISTORY ONLY INCLUDES 1 SAMPLE, THAT WAS PROCESSED AFTER THE MERGING EVENT. THE RESULTS PRIOR TO THIS EVENT ARE NOW INCLUDED IN PATIENTS' CXXXXXX, MXXXXXX FILE. IN INVESTIGATING THE INCIDENT INVOLVING IH-COM SENDING THE WRONG RESULT TO THE WRONG PATIENT, A DETAILED ANALYSIS OF THE DATABASE PROVIDED DURING THE CASE ESCALATION WAS CONDUCTED, SPECIFICALLY FOCUSING ON IH-COM VERSION 5.0.9. THE EXAMINATION REVEALED THAT THE ISSUE STEMMED FROM A MANUAL DATA MERGING ACTION BY THE LAB USER "JZL" ON JANUARY 9TH AT 03:09. DURING THIS OPERATION, PATIENT CXXXXXX (MRN (B)(6)) WASCOMBINED WITH PATIENT GXXXXX (MRN (B)(6)). DESPITE THE SOFTWARE'S STANDARD PROTOCOL OF ISSUING A WARNING MESSAGE BEFORE MERGING DATA, "JZL" ACKNOWLEDGED THE WARNING AND PROCEEDED WITH THE OPERATION, RESULTING IN THE INTEGRATION OF GXXXXX'S DATA INTO CXXXXXX'S FILE. IMPORTANTLY, THERE IS NO EVIDENCE OF A SOFTWARE MALFUNCTION. WE POINTED OUT TO THE USER THE IMPORTANCE OF ATTENTIVENESS AND ADHERENCE TO SYSTEMWARNINGS DURING MANUALDATA MANIPULATIONS. THE SOFTWARE CONTINUES TO OPERATE AS DESIGNED, AND WE RECOMMENDED REINFORCING TO THE USER AWARENESS TO MINIMIZE THE LIKELIHOOD OF SIMILAR INCIDENTS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463213 IH-COM V5.0 IH-COM V5.0 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 07611969234417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IH-1000, SN (B)(6).