BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    MDR report key: 5278825 · Received December 9, 2015

    Report

    Report Number
    2250051-2015-00077
    Event Type
    Injury
    Date Received
    December 9, 2015
    Date of Event
    October 19, 2015
    Report Date
    December 9, 2015
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING ON GEL CARD, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. ALL RESULTS WERE SATISFACTORY. REAGENT RED CELLS HAD EXPIRED PRIOR TO REPORT BY CUSTOMER. SAMPLE WAS NOT RETURNED TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTING ADVERSE REACTION FOR ONE PATIENT WHO SUFFERED A TRANSFUSION REACTION. ACCORDING TO CUSTOMER, PATIENT WAS ADMITTED TO THEIR EMERGENCY DEPT ON (B)(6) 2015 ( DIAGNOSIS NOT PROVIDED). SAMPLE WAS TESTED ON PROVUE ON (B)(6) 2015 AND ABS SCREEN WAS REPORTED NEGATIVE. SITE PERFORMED IMMEDIATE SPIN CROSSMATCH AND 2 UNITS OF "PACKED RED CELLS " WERE TRANSFUSED. PATIENT WAS DISCHARGED FROM FACILITY (DATE NOT PROVIDED). CUSTOMER FURTHER STATED PATIENT IN QUESTION WAS THEN ADMITTED TO SISTER FACILITY ON (B)(6) 2015 AND WITH REPEAT TESTING USING A NON-ORTHO INSTRUMENT, ABS SCREEN WAS REPORTED POSITIVE. ( ANTI-E AND ANTI-LITTLE C) WERE ID. PATIENT SUFFERED TRANSFUSION REACTION WITH POSITIVE ABS SCREEN. INITIALLY PRODUCT LOT NUMBERS NOT PROVIDED. ACCORDING TO CUSTOMER, SITE REPEATED THE ABS ON SAMPLE DRAWN ON (B)(6) 2015 AGAIN ON PROVUE ON (B)(6) 2015 AND 1+ REACTION WAS NOTED. ADDITIONAL TESTING ON DONOR UNITS CONFIRMED, BOTH UNITS WERE POSITIVE FOR E AND LITTLE C ANTIGENS. CUSTOMER DID STATE THAT ACCORDING TO SISTER FACILITY, ELUATE WAS POSITIVE AND ANTI-E AND LITTLE C WERE ID. CUSTOMER FURTHER ADDED THAT PATIENT IS CURRENTLY IN SISTER FACILITY UNDER MEDICAL TREATMENT FOR DIC ( DISSEMINATED INTRAVASCULAR COAGULATION). OCD REQUEST ADDITIONAL INFORMATION ON LOT # OF SCREENING CELLS/ GEL CARDS ON BOTH DAYS OF TESTING. CUSTOMER DID STATED THAT DAILY QC TESTING WERE PERFORMED AND ACCEPTABLE. ISSUE STARTED ON: (B)(6) 2015; REPORTED 11/18/15. FREQUENCY: 1X. OCD REQUESTED ADDITIONAL INFORMATION: LOT # , DIAGNOSIS FOR INITIAL ADMITTANCE, COPY OF TRANSFUSION WORK-UP. ON 18 NOV 2015, OCD TRIED REPEATEDLY (3X) TO CONTACT FACILITY FOR ADDED INFORMATION. HOWEVER, CUSTOMER HAS NOT RETURN OCD CALL. LEFT VOICE MESSAGE ON 19 NOV 2015, OCD TRIED TO CONTACT CUSTOMER AGAIN. INDICATED SITE WILL COLLECT THE REQUIRED INFORMATION AND WILL CONTACT OCD. ON 19 NOV 2015, MSO REQUESTING CTS TO ASK THE CUSTOMER FOR THE FOLLOWING INFORMATION: WHEN (HOW MANY HOURS OR DAYS POST-TRANSFUSION) DID THE PATIENT EXPERIENCE THE TRANSFUSION REACTIONS; WHAT ARE THE SIGNS AND SYMPTOMS; WERE THERE TEST RESULTS INDICATING HEMOLYSIS - E.G. HB AND BILIRUBIN; DOES THE PHYSICIAN CONSIDER THE DIC WAS LINKED TO OR CAUSED BY THE TRANSFUSION REACTION; DOES THE LAB STILL HAVE THE IMAGE OF THE ORIGINAL ABS TEST RESULT ON (B)(6), WHICH SHOWED NEGATIVE; WAS ANYTHING, E.G. REAGENTS OR CARDS, CHANGED BETWEEN THE TESTS CONDUCTED ON (B)(6) VS. (B)(6) WITH THE SAME SAMPLE. ON 20 NOV 2015, CUSTOMER CONTACTED OCD AND PROVIDED COPIES OF ABS SCREEN PERFORMED ON PROVUE ON (B)(6) 2015 AND ON (B)(6) 2015. CUSTOMER SENT COPY QC AND OF "TRANSFUSION WORK" PERFORMED AT THEIR FACILITY. ON 20 NOV 2015, OCD SPOKE WITH CUSTOMER: BASED ON INFORMATION PROVIDED BY CUSTOMER, PATIENT WAS AT FACILITY ON (B)(6) 2015 FOR DIAGNOSIS OF ANEMIA. ABS SCREEN WAS PERFORMED USING 0.8% SELECTOGEN LOT # VS871 AND MTS ANTI-IGG GEL CARD AND ABS WAS REPORTED AS NEGATIVE. CUSTOMER SITE FAILED TO PERFORM 'ANTIBODY HISTORY" ON PATIENT WHO HAD PREVIOUS HISTORY OF ANTI-E AND ANTI-LITTLE C. SITE PERFORMED IS CROSSMATCH AND TWO UNITS TRANSFUSED. LATER TESTING INDICATED THAT BOTH DONOR UNITS WERE POSITIVE FOR BOTH E AND LITTLE C ANTIGENS. PATIENT WAS RELEASED AND SENT BACK TO NURSING HOME. ON (B)(6), SAMPLE FROM PATIENT TAKEN AT THE NURSING HOME FOR CBC, INDICATED PATIENT'S HGB WAS 7.2 MG/DL. REPEAT TESTING ON (B)(6) = 7.9 MG/DL. ON (B)(6) HGB WAS 9.2 MG/DL. ON (B)(6) HGB WAS 8.4 MG/DL. ON (B)(6) HGB WAS 8.5 MG /DL. CUSTOMER ADDED ON 11/12, PATIENT WAS ADMITTED AT SISTER FACILITY AND TWO UNITS OF PACKED CELLS TRANSFUSED. HGB ON (B)(6), PRIOR TO TRANSFUSION WAS 7.6 MG/DL. UPON FURTHER INVESTIGATION, TRANSFUSION WORK-UP WAS INITIATED BY FACILITY. REPEAT TESTING OF SAMPLE DRAWN ON (B)(6), USING DIFFERENT LOT # OF SCREENING CELLS SHOWED POSITIVE REACTION WITH ABS SCREEN GEL CARDS LOT # WAS THE SAME THROUGH ALL TESTING. CUSTOMER FURTHER ADDED PATIENT IS STILL IN HOSPITAL (CANNOT TELL IF DIC CONDITION WAS DUE TO DELAY TRANSFUSION REACTION OR PATIENT'S MEDICAL DIAGNOSIS OF SEPSI AND ANEMIA. MEDICAL CONDITION HAS IMPROVED ACCORDING TO CUSTOMER). AS FOR BILIRUBIN VALUES, CUSTOMER REFUSED TO PROVIDE DETAILS. INDICATED THAT IS NOT REQUIRED BY ORTHO. ALSO CUSTOMER DID INDICATED FACILITY WILL BE FILLING A REPORT WITH THE FDA. ON 23 NOV 2015, SRMS IS REQUESTING CTS TO ASK CUSTOMER IF PRE AND POST TRANSFUSION PLASMA SAMPLES ARE AVAILABLE TO SHIP TO OCD FOR FURTHER INVESTIGATION. LOT VS871 EXPIRED ON 10 NOV 2015 SO OCD IS UNABLE TO PERFORM RETAIN TESTING. CUSTOMER IS UNABLE TO PROVIDE RETURN SAMPLES TO OCD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813147 ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS871

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O