BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG,-C3D POLYSPECIFIC (RABBIT) MTS¿ ANTI-IGG,-C3D CARD

    MDR report key: 8886126 · Received August 12, 2019

    Report

    Report Number
    1056600-2019-00029
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT AND MASTER LOT. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED CUSTOMER ISSUE WAS UNABLE TO BE CONFIRMED. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    REPORT 2 OF 2; (MXP 2151142) VISION: (B)(4). ACCOUNT REPORTS TWO PATIENTS WITH DISCREPANCIES BETWEEN MTS POLY GEL TESTING AND IMMUCOR POLY TUBE TESTING. BOTH REAGENTS ARE ANTI-IGG,-C3D REAGENTS. PATIENT 1: FALSE POSITIVE WITH BOTH VISIONS (NOT PHS EVENT). 1+ POSITIVE IN GEL; NEGATIVE IN TUBE (COMPETITOR REAGENT); PATIENT HAS A HISTORY OF BEING NEGATIVE. PATIENT 2: FALSE NEGATIVE WITH BOTH VISIONS (MXP 2151128, MXP 2151142). NEGATIVE IN GEL; 1+ POSITIVE IN TUBE (COMPETITOR REAGENT) ; PATIENT HAS A HISTORY OF BEING POSITIVE. IGG CARD LOT#: 042919005-01. TUBE REAGENT IS FROM IMMUCOR. ACCOUNT PERFORMED TESTING ON TWO VISIONS WITH THE SAME RESULTS: 50002984 AND 50002985. ISSUE STARTED ON: (B)(6) 2019. REPORTED: (B)(6) 2019. REACTION GRADE OBTAINED: 1+ OR NEGATIVE. CUSTOMER WAS EXPECTING: CONSISTENT RESULTS. TEST REPEATED: YES ON SECOND VISION. METHOD/RESULT OBTAINED BY REPEATING: SAME RESULTS. NUMBER OF SAMPLES AFFECTED? TWO. WAS QC AFFECTED? NO. DAILY QC PERFORMED AND FOUND TO BE ACCEPTABLE. CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE: PER IFU. CASSETTE/GEL CARD ORIENTATION: UPRIGHT. RBC STORAGE AND HANDLING: PER IFU. VISUAL APPEARANCE BEFORE USE: ALL REAGENTS HAVE A NORMAL APPEARANCE PRIOR TO USE. REPEATED TESTING IN TUBE AND PERFORMED TESTING ON TWO VISIONS WITH THE SAME RESULTS. ACCOUNT DOES NOT HAVE A MANUAL WORKSTATION TO RULE OUT THE VISION BOTH REAGENTS ARE IGG C3D REAGENTS. SAMPLES WERE COLLECTED ON JULY 17. BOTH WERE OUTPATIENTS SO NEW SAMPLES COULD NOT BE COLLECTED. QC IS ACCEPTABLE. ELUTION ONLY PERFORMED ON THE SAMPLE THAT WAS POSITIVE IN GEL AND NEGATIVE IN TUBE. ELUTION WAS NEGATIVE. ACCOUNT CONSIDERS TUBE TESTING AS TEST OF RECORD AS THAT IS HOW THEY VALIDATED THEIR VISIONS. ACCOUNT REPORTED OUT TUBE RESULTS. PATIENT WITH A POSITIVE DAT IN TUBE HAD A HISTORY OF BEING POSITIVE. PATIENT POSITIVE IN GEL AND NEGATIVE IN TUBE HAD A HISTORY OF BEING NEGATIVE. REVIEWED WITH ACCOUNT DIFFERENCES IN METHODOLOGIES. ACCOUNT UNDERSTANDS THIS, BUT HAS DISCONTINUED DAT TESTING ON THE VISION. ACCOUNT DOES NOT WANT ANOTHER LOT SHIPPED TO THEM. THEY HAVE DISCONTINUED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680283 ANTI-HUMAN GLOBULIN ANTI-IGG,-C3D POLYSPECIFIC (RABBIT) MTS¿ ANTI-IGG,-C3D CARD MTS GEL CARDS- FOR DIRECT ANTIGLOBULIN TEST KSZ MICROTYPING SYSTEMS 042919005-01

    Patients

    Seq Age Sex Outcome Treatment
    1