BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE

    MDR report key: 8637675 · Received May 23, 2019

    Report

    Report Number
    2250051-2019-00020
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 23, 2019
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    REPORT 2 OF 3. ORTHO RECEIVED AN EMAIL FROM AN ORTHO ACCOUNT MANAGER ON BEHALF OF THE CUSTOMER REPORTING A DISCREPANT RESULT FOR RH TYPING FOR ONE PATIENT USING ORTHO ANTI-D BIOCLONE LOT # DB325A1 EXP 28NOV2020; TESTED IN TUBE METHODOLOGY. CUSTOMER STATES THAT PREGNANT PATIENT WAS FIRST TESTED AT THIS CUSTOMER CLINIC ON (B)(6) 2018 FOR INITIAL WORK UP AND RESULTS OF RH NEGATIVE WAS REPORTED TO CLINICIAN, THAT INCLUDED WEAK D PHASE TESTING. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR DELIVERY AND TESTING WAS PERFORMED AT THE HOSPITAL WITH A NON-ORTHO ANTI-D ANTISERA AND 2+ RH POSITIVE RESULTS WERE OBTAINED. BECAUSE OF THE DISCREPANCY, THE HOSPITAL CALLED THE CLINIC EXPLAINING THE RESULTS THEY OBTAINED. THE CUSTOMER AT THE CLINIC BROUGHT LOT# DB325A1 OF ORTHO ANTI-D BIOCLONE TO THE HOSPITAL (WHICH WAS CLOSE-BY) AND TESTED THE SAME PATIENT SAMPLE AND AGAIN SAW A DISCREPANT RH NEGATIVE RESULT AT THE AHG PHASE OF TESTING. AN ADDITIONAL SAMPLE WAS THEN DRAWN FROM THE PATIENT, AND ORTHO ANTI-D BIOCLONE AGAIN SHOWED FALSE NEGATIVE RH RESULTS AT THE AHG PHASE OF TESTING. ISSUE STARTED ON: (B)(6) 2018 (DAY UNKNOWN); EMAIL SENT TO ORTHO AM ON 5/3/2019, THAT WAS THEN SENT TO TSC ON 5/7/19. FREQUENCY: 3X. SAMPLE ID: ONE PATIENT. METHODOLOGY USED: MANUAL TUBE. INCUBATION TIME (FOR MANUAL TEST ONLY): AHG PHASE. PATTERN OBSERVED: DISCREPANT RESULTS. REACTION GRADE OBTAINED: NEGATIVE. OTHER RELEVANT DETAILS: FIRST DATE OF TESTING WAS (B)(6) 2018 WITH SAMPLE WITH NO PREVIOUS HISTORY AT CLINIC. DAILY QC TESTING PERFORMED AND ACCEPTABLE TSC DISCUSSED ISSUE BEING ISOLATED TO PATIENT AND REVIEWED THE DIFFERENCE OF CLONES USED WITH DIFFERENT MANUFACTURES AND SAMPLE MAY CONTAIN A POSSIBLE RH D VARIANT ON 14MAY2019, TSS CONTACTED THE CUSTOMER TO ASK IF RHOGAM WAS ADMINISTERED DUE TO THE FALSE NEGATIVE ERRONEOUS RESULTS REPORTED. ON 16MAY2019, TSS CONTACTED THE CUSTOMER AGAIN TO ASK IF RHOGAM WAS ADMINISTERED DUE TO THE FALSE NEGATIVE ERRONEOUS RESULTS REPORTED. ON 20MAY2019, EMAIL WAS RECEIVED FROM CUSTOMER STATING THAT PATIENT WAS ORIGINALLY TESTED AT THEIR CLINIC ON (B)(6) 2018 AND PATIENT TESTED AS A GROUP O, RH NEGATIVE, INCLUDING WEAK D TESTING THAT WAS NEGATIVE AT THE AHG PHASE. PATIENT WAS ADMINISTERED RHOGAM ON (B)(6) 2019 AT 26 WEEKS AND 6 DAYS ANTEPARTUM DOSAGE. RHOGAM INJECTION: STRENGTH: 300 MCG, ROUTE: INTRAMUSCULAR, INJECTION SITE: RIGHT GLUTEUS, LOT #: RVP282A1, EXP. DATE: 06/29/2020. PATIENT GAVE BIRTH ON (B)(6) 2019 AND HOSPITAL TYPED HER AS GROUP O, RH POSITIVE SO NO RHOGAM WAS ADMINISTERED POST-PARTUM. CONSULT REQUESTED ON (B)(6) 2019 FROM THE MSO SINCE PATIENT RECEIVED ANTI-PARTUM RHOGAM DUE TO DISCREPANT FALSE NEGATIVE RH RESULTS REPORTED TO THE CLINICIAN. ON 21MAY2019, MSO WROTE: A PREGNANT PATIENT WAS TYPED AS RH D NEGATIVE USING THE ORTHO REAGENT IN (B)(6) 2018. ON (B)(6) AT DELIVERY, THE PATIENT WAS TYPE RH D POSITIVE WITH A 2+ REACTIVITY USING A NON-ORTHO METHOD. THE SAME SAMPLE WAS TESTED NEGATIVE USING THE ORTHO METHOD AS WELL AS AN ADDITIONAL BLOOD DRAW. THE PATIENT RECEIVED RHOGAM AT HER 26 WEEKS PREGNANCY AND 6 DAYS ANTEPARTUM DOSAGE BECAUSE OF THE RH D NEGATIVE TYPING RESULT USING THE ORTHO-METHOD, AND NO RHOGAM WAS ADMINISTERED POST-PARTUM AS SHE WAS TYPED AS RH D POSITIVE USING THE NON-ORTHO METHOD. THE REACTIVITY STRENGTH OF THE RH D TYPING USING THE NON-ORTHO METHOD WAS 2+, INDICATING THIS PATIENT PROBABLY EXPRESSED WEAK D OR PARTIAL D. MOLECULAR TEST IS NEEDED TO DETERMINE PATIENT¿S RH D STATUS. PATIENT WITH WEAK D CAN BE TREATED AS D POSITIVE, HOWEVER PATIENT WITH PARTIAL D SHOULD BE TREATED AS D NEGATIVE AND SHOULD RECEIVE RHOGAM TO PREVENT SENSITIZATION AND FUTURE HEMOLYTIC DISEASES FOR NEWBORNS. IN THIS CASE, WITHOUT KNOWING THE PATIENT¿S D STATUS, IT IS NOT CLEAR IF THE PROPHYLACTIC RHOGAM TREATMENT WAS UNNECESSARY. REGARDLESS, SINCE RHOGAM IS A SAFE AND WELL-TOLERATED DRUG, IF THE PATIENT DID NOT DEVELOP ANY ACUTE ADVERSE REACTION TO THE DRUG, E.G. ALLERGIC RESPONSES, LONG TERM HEALTH RISK IS NOT ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432461 ORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE ANTISERA KSZ ORTHO CLINICAL DIAGNOSTICS DB325A1

    Patients

    Seq Age Sex Outcome Treatment
    1