BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL B

    MDR report key: 6321791 · Received February 10, 2017

    Report

    Report Number
    2250051-2017-00011
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 9, 2017
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PRODUCT EVENT 3 OF 3. CUSTOMER REPORTED A FALSE NEGATIVE FOR ANTI-KELL IN MANUAL GEL METHOD WITH FOLLOWING EVENTS: FALSE NEGATIVE WITH CELL# 3 WITH ONE PATIENT WHEN TESTING WITH OPENED 0.8% SURGISCREEN LOT# VSS874 WITH MTS IGG GEL CARD LOT#101016001-01 ((B)(4)). FALSE NEGATIVE CELL# 11 WITH 3 SEPARATE PATIENTS WHEN TESTING WITH 0.8% RESOLVE PANEL A LOT# VRA266 EXP: 1-31-2017 WITH MTS IGG GEL CARDS LOT# 101016001-01. ALL THREE PATIENTS REACTED WITH PANEL CELL #7 (HOMOZYGOUS FOR KELL) WITH 1+ REACTIVITY. FALSE NEGATIVE CELL# 22 WITH ONE PATIENT WHEN TESTING WITH 0.8 RESOLVE PANEL B LOT#VRB227 WITH MTS IGG GEL CARDS LOT# 101016001-01 ((B)(4)). PATIENT DID REACT WITH PANEL CELL #17 WITH 1+ REACTIVITY. ORTHO CARE ASKED CUSTOMER WHAT INITIATED CUSTOMER TO PERFORM ANTIBODY IDENTIFICATION PANELS IF ANTIBODY SCREEN WAS NEGATIVE FOR CELL #3, AND CUSTOMER STATED THE TWO PATIENTS HAD PREVIOUS HISTORY OF ANTI-KELL. CUSTOMER RAN THE PANELS BECAUSE IT IS PART OF THEIR PROTOCOL TO RUN A PANEL ON PATIENTS WITH PREVIOUS HISTORY OF AN ANTIBODY. CUSTOMER RAN 0.8% RESOLVE PANEL B AND IMMUCOR PANEL FOR IDENTIFICATION AND TO RULE OUT. ISSUE STARTED ON: (B)(6) 2017, REPORTED 1-19-1207, FREQUENCY: 3 PATIENTS. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: CELL 22; METHODOLOGY USED: MANUAL GEL METHOD ; INCUBATION TIME (FOR MANUAL TEST ONLY): 15 MIN; PATTERN OBSERVED: FALSE NEG; REACTION GRADE OBTAINED: NEG ; CUSTOMER WAS EXPECTING: POS; TEST REPEATED: YES; RESULT OBTAINED BY REPEATING:NEG ; METHOD USED TO REPEAT: MANAUL GEL METHOD; CUSTOMER REPORTS STORING RED CELL REAGENTS AND MTS GEL CARDS ACCORDING TO IFU. CUSTOMER REPORTS NO SIGNS OF HEMOLYSIS OR HAZE NOTED IN RED CELL REAGENTS. QC DATA: QC TYPE: ALBA Q-CHEK; LAST QC RUN: (B)(6) 2017. CARDS /CASSETTES/ STORAGE CONDITION TEMPERATURE: AS PER IFU; VISUAL APPEARANCE BEFORE USE: ACCEPTABLE; REAGENT RED BLOOD CELL STORAGE AND HANDLING: AS PER IFU. PROTOCOL DETAILS (FOR CUSTOMER WORKING IN MANUAL METHODS): PIPETTE USED:TIPMASTER PIPETTOR. MAINTENANCE UP TO DATE. ORTHO CARE ASKED THE CUSTOMER TO TEST WITH AN ALTERNATE LOT OF IGG GEL CARDS, BUT CUSTOMER DID NOT HAVE AN ALTERNATE LOT. ORTHO CARE ASKED CUSTOMER IF RED CELL REAGENTS WERE ALLOWED TO COME TO ROOM TEMPERATURE, CUSTOMER REPORTS YES. ORTHO CARE ASKED CUSTOMER TO TEST SCREENING CELL #3 WITH AN ANTI-KELL ANTISERA. TESTED SCREENING CELL #3 WITH IMMUCOR ANTI-KELL ANTISERA DILUTED WITH BLOOD BANK SALINE WITH REACTIVITY AT 3+ WITH A 1:16 DILUTION IN TUBE METHOD. ORTHO CARE DISCUSSED WITH THE CUSTOMER THAT THE ISSUE IS SAMPLE RELATED, BUT CUSTOMER IS NOT SATISFIED WITH THIS LOT OF SCREENING CELLS. REPLACEMENT IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103950 REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL B REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRB227

    Patients

    Seq Age Sex Outcome Treatment
    1