BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN

    MDR report key: 12914104 · Received December 1, 2021

    Report

    Report Number
    2250051-2021-00068
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 1, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MXP2393978. QERTS# 499860. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS: (B)(6). DISCORDANT NEGATIVE ANTIBODY SCREENING RESULTS FOR TWO SAMPLES FROM ONE PATIENT HAVING AN ANTI-M(MNS1) ANTIBODY. THE MOST PROBABLE ROOT-CAUSE IS SAMPLE-RELATED, PATIENT¿S ANTI-M(MNS1) ANTIBODY BEING WEAK AND/OR AT DETECTION LIMIT OF THE REAGENTS AND TECHNIQUES USED AND/OR ASSOCIATED WITH THE VARIABILITY OF EXPRESSION OF M(MNS1) ANTIGENS PRESENT ON REAGENT RED BLOOD CELLS. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. A NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN IN (B)(6) 2021. THE PATIENT WAS NOT HARMED BECAUSE OF THESE EVENTS.

    Description of Event or Problem · 0

    REPORT 2 OF 2 A CUSTOMER CONTACTED ORTHO CARE ON 05 NOVEMBER 2021 AFTER OBSERVING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) RESULTS FOR A PATIENT USING 0.8% SURGISCREEN® LOT VSS307 (EXPIRY DATE 05 OCTOBER 2021) IN MANUAL ID-MICRO TYPING SYSTEM¿ GEL TEST METHOD. COMPLAINANT NAME: (B)(6), POSITION NOT PROVIDED. COMPLAINT REPORTER NAME: (B)(6), ORTHO LABORATORY SPECIALIST. EVENTS DATE: (B)(6) 2021 AND (B)(6) 2021. PATIENT INFORMATION: SAMPLE 1 DRAWN ON 28 SEPTEMBER. SAMPLE 2 DRAWN ON (B)(6) 2021. THE PATIENT DID NOT RECEIVE ANY PRODUCTS BETWEEN (B)(6) 2021 AND (B)(6) 2021. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED SAMPLE 1 FROM THIS PATIENT FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN® VSS307 IN MANUAL ID-MICRO TYPING SYSTEM¿ GEL TEST METHOD OBTAINING A POSITIVE REACTION WITH CELL 1 (LIGHT 1+ REACTION STRENGTH) AND NEGATIVE REACTIONS WITH CELLS 2 AND 3 OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RE-TESTED THE SAME SAMPLE FOR ANTIBODY SCREENING IN IAT USING THE SAME REAGENT AND METHOD OBTAINING NEGATIVE REACTIONS WITH THE THREE CELLS OF THE RED CELL REAGENT. A NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN ON (B)(6) 2021. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED THE SAMPLE 2 FROM THIS PATIENT FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN® VSS311 (EXPIRY DATE 19 OCTOBER 2021) IN MANUAL ID-MICRO TYPING SYSTEM¿ GEL TEST METHOD OBTAINING A POSITIVE REACTION WITH CELL 2 (2+ REACTION STRENGTH) AND NEGATIVE REACTIONS WITH CELLS 1 AND 3 OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED THE SAMPLE 1 FOR ANTIBODY SCREENING IN IAT USING THE SAME REAGENT AND METHOD OBTAINING A POSITIVE REACTION WITH CELL 2 (REACTION STRENGTH NOT PROVIDED) AND NEGATIVE REACTIONS WITH CELLS 1 AND 3 OF THE RED CELL REAGENT. IT IS UNDERSTOOD THAT ON THE SAME DAY, THEY HAD TESTED THE SAMPLE 2 FOR ANTIBODY SCREENING IN IAT USING THE 0.8% SURGISCREEN® VSS307 AND 0.8% SURGISCREEN® VSS311 IN MANUAL ID-MICRO TYPING SYSTEM¿ GEL TEST METHOD OBTAINING: NEGATIVE REACTIONS WITH THE THREE CELLS OF THE RED CELL REAGENT LOT VSS307 (EXPIRED SINCE 05 OCTOBER 2021). A POSITIVE REACTION WITH CELL 2 (REACTION STRENGTH NOT PROVIDED) AND NEGATIVE REACTIONS WITH CELLS 1 AND 3 OF THE RED CELL REAGENT LOT VSS311. IT IS FURTHER UNDERSTOOD THAT THE SAMPLE WAS SENT FOR ANTIBODY IDENTIFICATION TO THE AMERICAN RED CROSS WHERE AN ANTI-M(MNS1) WAS IDENTIFIED. IT IS UNDERSTOOD THAT THE PRESENCE OF AN ANTI-M(MNS1) ANTIBODY WAS REPORTED TO THE PHYSICIAN IN (B)(6) 2021. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED BECAUSE OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805176 ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VSS307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown