BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-COM V5.0

    MDR report key: 15091568 · Received July 25, 2022

    Report

    Report Number
    9610824-2022-00037
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 2, 2022
    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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT IH-COM ON THE IH-1000 INSTRUMENT ASSIGNED AN INCORRECT TEST RESULT TO A PATIENT. IN IH-COM, THE FIRST 2 DIGITS OF THE CUSTOMER NUMBER IS FOR THE YEAR (I.E., 21=2021; 22=2022, ETC.). THE CUSTOMER ERRONEOUSLY SELECTED A PATIENT FROM (B)(6) 2021 INSTEAD OF (B)(6) 2022 (SAME ID NUMBER EXCEPT FOR THE "22" IN FRONT OF THE NUMBER), AND THE ORIGINAL IMAGE WELL RESULTS WERE STILL PRESENT. THE RESULT WAS RELEASED BEFORE IT WAS NOTICED, AND THE ACTUAL PATIENT ((B)(6) 2022) WAS A DIFFERENT BLOOD TYPE. THE CUSTOMER HAD TO PROCESS A CORRECTED REPORT. THE CUSTOMER WAS QUESTIONING WHEN THE ORIGINAL IMAGES DISAPPEAR AND ARE REPLACED BY A "RENDERING" OR A PICTURE REPRESENTATION. IH-COM DATA FILES WERE RECEIVED FOR INVESTIGATION BUT WERE CORRUPT. FOR THIS REASON, WE COULDN'T YET ANALYZE THE CUSTOMER SPECIFIC DATA BASE YET. BUT GENERALLY IN IH-COM ONE HAS THE POSSIBILITY TO "REOPEN VERIFIED OR VALIDATED TESTS". THIS IS ONLY POSSIBLE BY A USER WITH THE RIGHTS 90 OR HIGHER (IH-COM ADMINISTRATORS). THE OPTION "RESEND" WILL SEND A RESULT AGAIN TO THE HOST/LIS. THIS MAY LEAD TO AN ISSUE AS THE LIS THE CUSTOMER IS USING IS NOT TAKING THE FIRST TWO DIGITS OF THE SAMPLE BARCODE INTO ACCOUNT. THE FIRST 2 DIGITS OF THE BAR CODE THE CUSTOMER IS USING IS FOR THE YEAR (I.E., 21=2021; 22=2022, ETC.). THIS OPTION IS AVAILABLE FOR NORMAL USERS (RIGHTS 50). WE ARE STILL WAITING FOR IH-COM DATA FILES THAT ARE NOT CORRUPT TO INVESTIGATE IF A MALFUNCTION OF THE SOFTWARE IS PRESENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT IH-COM ON THE IH-1000 INSTRUMENT ASSIGNED AN INCORRECT TEST RESULT TO A PATIENT. IN IH-COM, THE FIRST 2 DIGITS OF THE CUSTOMER NUMBER IS FOR THE YEAR (I.E., 21=2021; 22=2022, ETC.). THE CUSTOMER ERRONEOUSLY SELECTED A PATIENT FROM 02021 INSTEAD OF 06/23/2022 (SAME ID NUMBER EXCEPT FOR THE "22" IN FRONT OF THE NUMBER), AND THE ORIGINAL IMAGE WELL RESULTS WERE STILL PRESENT. THE RESULT WAS RELEASED BEFORE IT WAS NOTICED, AND THE ACTUAL PATIENT ((B)(6) 2022) WAS A DIFFERENT BLOOD TYPE. THE CUSTOMER HAD TO PROCESS A CORRECTED REPORT. THE CUSTOMER WAS QUESTIONING WHEN THE ORIGINAL IMAGES DISAPPEAR AND ARE REPLACED BY A "RENDERING" OR A PICTURE REPRESENTATION. IH-COM DATA FILES WERE RECEIVED FOR INVESTIGAION BUT WERE CORRUPT. FOR THIS REASON, WE COULDN'T YET ANALYZE THE CUSTOMER SPECIFIC DATA BASE YET. BUT GENERALLY IN IH-COM ONE HAS THE POSSIBILITY TO "REOPEN VERIFIED OR VALIDATED TESTS". THIS IS ONLY POSSIBLE BY A USER WITH THE RIGHTS 90 OR HIGHER (IH-COM ADMINISTRATORS). THE OPTION "RESEND" WILL SEND A RESULT AGAIN TO THE HOST/LIS. THIS MAY LEAD TO AN ISSUE AS THE LIS THE CUSTOMER IS USING IS NOT TAKING THE FIRST TWO DIGITS OF THE SAMPLE BARCODE INTO ACCOUNT. THE FIRST 2 DIGITS OF THE BAR CODE THE CUSTOMER IS USING IS FOR THE YEAR (I.E., 21=2021; 22=2022, ETC.). THIS OPTION IS AVAILABLE FOR NORMAL USERS (RIGHTS 50). A NEW DATA BASE WAS COLLECTED FOR INVESTIGATION. THE DATA BASE DOES NOT SHOW ANY TRACES THAT THE SAMPLE IN QUESTION HAS BEEN REVALIDATED. THIS INFORMATION WOULD STAY IN THE DATA BASE WITHOUT ANY LIMITATION. OUR INVESTGATION TEAM SEARCHED THE CONCERNED TIME RANGE FOR SIMILAR ENTRIES BUT COULDN'T FIND ANY. THIS MEANS THAT THE USER MOST PROBABLY USED THE MANUAL "SEND RESULT" FUNCTION. THIS IS TRACED AS WELL BUT THIS INFORMATION (MESSAGE IN BLACK) WILL BE DELETED AFTER 7 DAYS AND IS THEREFORE NO MORE AVAILABLE IN THE TRACES/DATA BASE THAT OUR TEAM HAVE RECEIVED FOR ANALYSIS. IT IS MOST LIKELY THAT THE USER HAS USED THE FUNCTION "SEND RESULT". THE RESULT HAS BEEN SENT AGAIN TO THE LIS, BUT HAS BEEN INTERPRETED IN A WRONG WAY AS IT IGNORES THE FIRST TWO DIGITS WHICH REPRESENT THE YEAR. NO ISSUE IN IH-COM HAS BEEN IDENTIFIED. ALL THE INVOLVED FUNCTIONS WORKED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560148 IH-COM V5.0 IH-COM V5.0 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 5.0.10 07611969234417

    Patients

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