BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER AC*T 5 DIFF CP ANALYZER

    MDR report key: 2140129 · Received June 25, 2011

    Report

    Report Number
    1061932-2011-00765
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CHECKED THE PROBE ALIGNMENT AND REPLACED THE SAMPLE SYRINGE. THE FSE RAN TWO REPRODUCIBILITY TESTS AND BOTH WERE WITHIN SPECIFICATIONS. THE INSTRUMENT HAD A TRANSFER SENOR TIMEOUT ERROR AND THE FLOWCELL INJECTOR TUBING WAS LOOSE. THE FSE RETURNED THE NEXT DAY AND REPLACED THE FLOWCELL INJECTOR TUBING AND ALIGNED THE FLOWCELL. THE FSE RAN ANOTHER REPRODUCIBILITY TEST. REPAIR WAS VERIFIED AND INSTRUMENT WAS VALIDATED. THE CUSTOMER WAS NOTIFIED AFTER THE SERVICE VISIT THAT THE DROP IN HGB AND RBC IS CONSISTENT WITH A PROBE MISALIGNMENT PROBLEM. IF THE ALIGNMENT IS OFF AND THEN AN ADJUSTMENT TO CORRECT THE ALIGNMENT WOULD RESOLVE THE DROP IN HGB & RBC. THE ROOT CAUSE CAN BE ATTRIBUTED TO ADJUSTMENTS AND HARDWARE REPLACED BY THE FSE DURING SUBSEQUENT INSTRUMENT SERVICING. PER LABELING, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE PATIENT LIMITS (H/L), ACTION LIMITS (HH/LL), PARAMETER FLAGS, INTERPRETIVE MESSAGES AND ANALYTICAL ALARMS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER ACT 5 DIFF CP ANALYZER GENERATED RED BLOOD COUNT (RBC) AND HEMOGLOBIN (HGB) RESULTS THAT WERE NOT REPRODUCING OVER TWO (2) CONSECUTIVE DAYS. THE SECOND DAY ((B)(6) 2011), ONLY FOUR (4) PATIENT RESULTS WERE INVOLVED IN THIS EVENT, WHICH IS PRESENTED IN THIS REPORT. THE SAMPLES WERE RERUN ON THE REFERENCE INSTRUMENT; HOWEVER THE REFERENCE PRINTOUT FOR PATIENT 1 WAS NOT PROVIDED. ERRONEOUS RESULTS WERE GENERATED AND CORRECTED REPORTS WERE ISSUED. PATIENT 2 RESULTS CORRELATED WELL ON ALL PARAMETERS EXCEPT FOR LOWER PLATELET (PLT) RESULTS. IN ADDITION TO THE LOWER RBC & HGB RESULTS, PATIENT 3 & 4 ALSO EXHIBITED LOWER PLT RESULTS. THE RESULTS PROVIDED BY THE CUSTOMER ARE PRESENTED IN THE ATTACHMENT SECTION OF THIS REPORT. ONE PATIENT, WITH A KNOWN DIAGNOSIS OF ANEMIA, WAS TREATED WITH AN ARANESP INJECTION. THE CUSTOMER WAS UNABLE TO LOCATE THIS PATIENT'S INCORRECT RESULT SO IT IS UNKNOWN WHICH PATIENT WAS AFFECTED IN THIS EVENT. THERE WAS NO OTHER EFFECT TO OTHER PATIENT'S AND NO OTHER CHANGE TO PATIENT TREATMENT. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT. MDR 1061932-2011-00764 DOCUMENTS THE PATIENTS INVOLVED ON THE FIRST DAY OF THIS EVENT ((B)(6) 2011).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T 5 DIFF CP ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T 5 DIFF CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other