BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO ANTI-HUMAN GLOBULIN_RABBIT

    MDR report key: 15018688 · Received July 14, 2022

    Report

    Report Number
    2250051-2022-00047
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 26, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EMAIL ADDRESS FOR CONTACT OFFICE IN MANUFACTURER NAME, CITY AND STATE, MANUFACTURER SITE & REPORT SOURCE IS: (B)(6). ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY 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. DISCREPANT NEGATIVE DAT RESULT FOR A NEWBORN SAMPLE IN MANUAL TUBE METHOD. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. A NEGATIVE DAT WAS REPORTED TO THE PHYSICIAN. THE NEWBORN WAS NOT HARMED.

    Description of Event or Problem · 0

    ON 28 JUNE 2022, A CUSTOMER CONTACTED ORTHOCARE AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE REACTION IN DIRECT ANTIGLOBULIN TEST (DAT) FOR ONE NEWBORN USING ANTI-HUMAN GLOBULIN ANTI-IGG LOT IG182B IN MANUAL TUBE METHOD. COMPLAINANT/COMPLAINT REPORTER: (B)(6) MEDICAL TECHNOLOGIST. DATE OF EVENT: (B)(6) 2022 REPORTED ON: 28 JUNE 2022 BY (B)(6) TO THE ORTHOCARE HELPDESK. REAGENTS: ANTI-HUMAN GLOBULIN ANTI-IGG LOT IG182B EXPIRY DATE 14 JULY 2023. IMMUCOR IGG ANTISERA LOT UNKNOWN EXPIRY DATE UNKNOWN. PATIENT INFORMATION: NEWBORN; CORD SAMPLE; MOTHER HAS A HISTORY OF ANTI-JSB. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD TESTED A NEWBORN SAMPLE FOR DAT TESTING USING ANTI-HUMAN GLOBULIN ANTI-IGG LOT IG182B IN MANUAL TUBE METHOD AND THAT THEY HAD OBTAINED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, BASED ON THE NEWBORN'S MOTHER'S HISTORY, THEY HAD RETESTED THIS NEWBORN SAMPLE FOR DAT TESTING USING AN ALTERNATIVE COMMERCIALLY AVAILABLE METHOD (IMMUCOR IGG ANTISERA LOT UNKNOWN) AND THAT THEY HAD OBTAINED A POSITIVE REACTION (2+ REACTION STRENGTH). THE CUSTOMER STATED THAT AN ELUATE WAS TESTED AND ANTI-JSB WAS IDENTIFIED. THE CUSTOMER REPORTED THAT A SAMPLE FROM THIS NEWBORN WAS SENT TO THEIR REFERENCE LABORATORY FOR ADDITIONAL TESTING AND THAT A POSITIVE DAT WAS OBTAINED AND THE PRESENCE OF AN ANTI-JSB WAS CONFIRMED. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT A NEGATIVE DAT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE NEWBORN HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279423 ORTHO ANTI-HUMAN GLOBULIN_RABBIT ANTI-HUMAN GLOBULIN QHS ORTHO CLINICAL DIAGNOSTICS IG182B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown