BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS

    MDR report key: 1841162 · Received September 22, 2010

    Report

    Report Number
    1034569-2010-00203
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 22, 2010
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED OPENED PRODUCT TO THE MANUFACTURER WITH NO HUMIDITY INDICATOR, AND SUBMITTED PATIENT SAMPLE. THE PRESENCE OF THE E ANTIGEN WAS CONFIRMED ON RETENTION PRODUCT. USING THE PATIENT SAMPLE AND RETENTION PRODUCTS, PERFORMED ANTIBODY SCREEN AND IDENTIFICATION ON THE ECHO; TUBE TESTING WITH PANOSCREEN III USING THE PATIENT SAMPLE; AND TUBE TESTING OF THE PATIENT SAMPLE AND ANTI-E AS A CONTROL WITH EXTENDED INCUBATION TIMES. ALL CONTROLS PERFORMED AS EXPECTED AND THE CUSTOMER'S SAMPLE WAS NEGATIVE WITH ALL CELLS. PERFORMED ANTIBODY SCREEN ON CUSTOMER'S SAMPLE IN TUBES USING RETENTION PRODUCT PANOSCREEN III. CONTROLS PERFORMED AS EXPECTED. CUSTOMER'S SAMPLE EXHIBITED NEGATIVE REACTIVITY WITH ALL CELLS. INVESTIGATION SUMMARY: CUSTOMER SENT PLASMA FROM THIS PATIENT FOR FURTHER INVESTIGATION. INITIAL INVESTIGATION WITH STRIP LOTS E031 AND E0029 RESOLVED NEGATIVE FOR ANTI-E (OTHER REAGENTS INVOLVED: CAPTURE R CELLS LOT 221564). CONFIRMED THE PRESENCE OF THE E ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (3) LOT E031, E029, AND CAPTURE-R READY-ID, LOT ID130 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS LOT 221567 AND ANTI-E LOT 7D630 (1:32 DILUTION). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. PERFORMED AN ANTIBODY SCREEN AND ID ON THE CUSTOMER'S SUBMITTED SAMPLE (B)(6) ON THE ECHO USING RETENTION PRODUCTS CAPTURE-R READY-SCREEN (3) (CRRS3) LOT E031, E029, CAPTURE-R READY-ID (CRRID), LOT ID 130 AND CAPTURE-R READY INDICATOR RED CELLS (CRRIRC) LOT 221569. CONTROLS PERFORMED AS EXPECTED AND THE CUSTOMER'S SUBMITTED SAMPLE REPORTED AS NEGATIVE WITH ALL CELLS ON THE CRRS3 AND CRRID. PERFORMED AN ANTIBODY SCREEN ON CUSTOMER'S SUBMITTED SAMPLE (B)(6) IN TUBES USING RETENTION PRODUCT PANOCELL I-III, LOT 30315. CONTROLS PERFORMED AS EXPECTED AND THE CUSTOMER'S SUBMITTED SAMPLE EXHIBITED NEGATIVE REACTIVITY WITH ALL CELLS. REPRODUCED CUSTOMER'S NEGATIVE RESULTS. PERFORMED AN ANTIBODY SCREEN ON CUSTOMER'S SUBMITTED SAMPLE (B)(6) AND ANTI-E LOT 954023 IN TUBES WITH EXTENDED INCUBATION TIMES USING RETENTION PRODUCT PANOCELL I-III, LOT 30315. THEY WERE TESTED AT RT (20 MINUTE INCUBATION) AND 37 DEGREES (50 MINUTE INCUBATION) THE ANTI-E CONTROL PERFORMED AS EXPECTED. THE CUSTOMER'S SUBMITTED SAMPLE EXHIBITED NEGATIVE REACTIVITY WITH ALL CELLS. NOT ABLE TO REPRODUCE THE POSITIVE ANTI-E RESULTS THAT THE CUSTOMER OBTAINED ON THE DIAMED GELCARD AND DIAMED PANEL. PRODUCT PACKAGE INSERT CARRIES THE FOLLOWING LIMITATION STATEMENT: "NO ONE TEST METHOD IS CAPABLE OF DETECTING ALL ANTIBODIES."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS FOR ANTI-E WITH THE CAPTURE-R READY-ID (CRRID) ASSAY ON THE ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS CAPTURE-R READY ID KSZ IMMUCOR, INC. ID130

    Patients

    Seq Age Sex Outcome Treatment
    1