BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 4743471 · Received May 1, 2015

    Report

    Report Number
    2919069-2015-00024
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 27, 2015
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND DATA LOG REVIEWS. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. CELL-DYN 3700, LIST NUMBER 02H31-01, SN (B)(4), TRANSMITTING ONE PATIENT RESULT EIGHT TIMES WITH EIGHT DIFFERENT PATIENT IDENTIFICATION NUMBERS. THE 8 PATIENT RESULTS SUBMITTED SHOWED THE SAMPLES WERE RUN ON (B)(6) 2015 BETWEEN 12:53 TO 14:26, AND WERE IDENTIFIED AS (B)(6). THE DATALOG SHOWED THAT CORRECT RESULTS WERE GENERATED FOR EACH OF THESE 8 PATIENT SAMPLES. THE RESULT DATA FOR (B)(6), WAS RUN ON (B)(6) 2015 AT 14:28. THE RESULT OF (B)(6) WAS TRANSMITTED IN THE LABORATORY INFORMATION SYSTEM (LIS) 8 TIMES BUT WAS ASSIGNED TO 8 DIFFERENT PATIENT IDENTIFICATION NUMBERS. THE CELL-DYN 3700 TRANSMIT LOG WAS NOT SUBMITTED BECAUSE IT WAS NOT AVAILABLE. THE ACTUAL DATA SENT BY THE CELL-DYN 3700 INSTRUMENT DATA STATION COULD NOT BE VERIFIED. DUE TO THE MISSING TRANSMIT LOG DATA FROM THE CELL-DYN 3700 DATA STATION, THE EXACT CAUSE OF THIS INCIDENT WAS UNDETERMINED BECAUSE THE COMMUNICATION WAS UNABLE TO BE VERIFIED BETWEEN THE CELL-DYN 3700 AND THE LIS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED THE CELL-DYN 3700 ANALYZER TRANSMITTING ONE PATIENT RESULT EIGHT TIMES WITH EIGHT DIFFERENT PATIENT IDENTIFICATION NUMBERS. THE 8 PATIENT RESULTS SUBMITTED FROM CELL-DYN 3700 SL, LIST NUMBER 02H31-01, SERIAL NUMBER (B)(4), SHOWED THE SAMPLES WERE RUN ON (B)(6) 2015 BETWEEN 12:53 TO 14:26, AND WERE IDENTIFIED AS SEQ. 1295 TO SEQ. 1349. THE DATALOG SHOWED THAT CORRECT RESULTS WERE GENERATED FOR EACH OF THESE 8 PATIENT SAMPLES. THE RESULT DATA FOR SEQ. 1351, SPECIMEN ID (B)(6), WAS RUN ON (B)(6) 2015 AT 14:28. THE RESULT OF SEQ.1351 WAS TRANSMITTED IN THE LABORATORY INFORMATION SYSTEM (LIS) 8 TIMES BUT WAS ASSIGNED TO 8 DIFFERENT PATIENT IDENTIFICATION NUMBERS. THE DATA FROM THE LIS SHOWED THE COMPLAINT INCIDENT; HOWEVER, THE CELL-DYN 3700 TRANSMIT LOG WAS NOT SUBMITTED BECAUSE IT WAS NOT AVAILABLE. THE ACTUAL DATA SENT BY THE CELL-DYN 3700 INSTRUMENT DATA STATION COULD NOT BE VERIFIED. DUE TO THE MISSING TRANSMIT LOG DATA FROM THE CELL-DYN 3700 DATA STATION, THE COMMUNICATION BETWEEN THE CELL-DYN 3700 AND THE LIS COULD NOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288056 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1