BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1232057 · Received November 18, 2008

    Report

    Report Number
    2919069-2008-00783
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Removal / Correction Number
    2919069-12/1/09-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PRODUCT MEETS RELIABILITY DATA. ABBOTT LABORATORIES RECEIVED AN INITIAL CUSTOMER COMPLAINT ALLEGING THE CELL-DYN INSTRUMENT DID NOT SIGNAL A WASTE FULL ALARM. ALTHOUGH THE ORIGINAL PART FOR THIS EVENT COULD NOT BE INVESTIGATED, THE INVESTIGATION OF THE REPORTED ISSUE DETERMINED THAT THE PART WAS IN USE GREATER THAN 2 YEARS. THE INVESTIGATION INTO RETURNED PARTS FROM THE FIELD SHOWED THAT ALL HAVE BEEN IN USE GREATER THAN 2 YEARS. IN-HOUSE INVESTIGATION OF THE RETURNED PARTS COULD NOT REPRODUCE THE OCCURRENCE OF THE INITIAL COMPLAINT. THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. THE WASTE OUTLET TUBE ASSEMBLY (LN 92161-02) HAS A LONG HISTORY OF BEING RELIABLE. THERE HAVE BEEN NO TRENDS IN THE PERFORMANCE OF THIS PART FROM A RELIABILITY PERSPECTIVE. IT HAS CONSISTENTLY MET RELIABILITY EXPECTATIONS. THE WASTE OUTLET TUBE ASSEMBLY HAS BEEN ON THE MARKET FOR OVER 10 YEARS, AND MEETS RELIABILITY EXPECTATIONS FOR THE CELL-DYN 1800 INSTRUMENT. IT CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. A REVIEW OF THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 07H80-01, REVISION E, SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION. THE WASTE OUTLET TUBE ASSEMBLY IS PERFORMING AS DESIGNED. THE RELIABILITY WAS DETERMINED TO BE ACCEPTABLE, AND THE PRODUCT IS MEETING EXPECTED SAFETY PERFORMANCE AS ESTABLISHED IN THE PRODUCT RISK MANAGEMENT FILE. ALTHOUGH THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE IF THE PRODUCT FAILS AT THE END OF ITS LIFE EXPECTANCY. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PRODUCT MEETS RELIABILITY DATA. UPON FURTHER REVIEW, THE CUSTOMER'S ISSUE IS NOW ASSOCIATED WITH REMEDIAL ACTION NUMBER 2919069-12/1/09-005-C. AN INVESTIGATION IS IN PROCESS, A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4) AN EXPANDED INVESTIGATION HAS BEEN CONDUCTED TO EVALUATE THIS ISSUE. THE INVESTIGATION OF THE RETURNED PARTS FROM THE FIELD SHOWED THAT THE PART HAS BEEN IN USE GREATER THAN TWO YEARS. ALTHOUGH, THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THIS PART WILL WEAR OUT AND THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. THEREFORE; THE PART WILL NEED PERIODIC REPLACEMENT AS IT IS IN CONTACT WITH BIOHAZARD MATERIAL AND CUSTOMER USAGE/HANDLING. THE PART CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. A REVIEW OF THE CELL-DYN SYSTEM OPERATORS MANUALS SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION FOR POTENTIAL CAUSES. ABBOTT RECOMMENDED A REPLACEMENT SCHEDULE FOR THE WASTE LINE ASSEMBLY FOR THE CELL-DYN SYSTEMS. THE WASTE BOTTLE CABLE IS A SUBCOMPONENT OF THE WASTE LINE ASSEMBLY, CHANGING THE WASTE LINE ASSEMBLY WILL RESULT IN CHANGING THE WASTE BOTTLE CABLE. AS PART OF THE CORRECTIVE ACTION, A PRODUCT CORRECTION LETTER, FA30NOV2009, WAS ISSUED TO ALL AFFECTED CUSTOMERS. IN THIS COMMUNICATION, ABBOTT RECOMMENDED REPLACING THE PART EVERY SIX MONTHS. AN UPDATE TO THE PRODUCT LABELING WILL BE ADDED AS WELL WITH REGARDS TO THIS RECOMMENDATION. A TAG THAT CAN BE AFFIXED TO THESE ITEMS WAS SENT WITH THE CUSTOMER LETTER. THIS TAG INCLUDES FIELDS TO RECORD INSTALLATION AND REPLACEMENT DATES. THE TAGS WILL ALSO BE INTRODUCED INTO REPLACEMENT ASSEMBLIES.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS (B)(4): OTHER, PRODUCT MEETS RELIABILITY DATA. ABBOTT LABORATORIES RECEIVED AN INITIAL CUSTOMER COMPLAINT ALLEGING THE CELL-DYN INSTRUMENT DID NOT SIGNAL A WASTE FULL ALARM. ALTHOUGH THE ORIGINAL PART FOR THIS EVENT COULD NOT BE INVESTIGATED, THE INVESTIGATION OF THE REPORTED ISSUE DETERMINED THAT THE PART WAS IN USE GREATER THAN 2 YEARS. THE INVESTIGATION INTO RETURNED PARTS FROM THE FIELD SHOWED THAT ALL HAVE BEEN IN USE GREATER THAN 2 YEARS. IN-HOUSE INVESTIGATION OF THE RETURNED PARTS COULD NOT REPRODUCE THE OCCURRENCE OF THE INITIAL COMPLAINT. THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. BASED ON THE INTENDED USE, THIS PART WILL WEAR OUT AND NEED PERIODIC REPLACEMENT AS IT IS IN CONTACT WITH BIOHAZARD MATERIAL AND CUSTOMER USAGE/HANDLING. IT CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. NO PREVENTIVE MAINTENANCE SCHEDULE WAS IN PLACE. A REVIEW OF THE CELL-DYN SYSTEM OPERATORS MANUALS SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION FOR POTENTIAL CAUSES. THE WASTE OUTLET TUBE ASSEMBLY IS PERFORMING AS DESIGNED. THE RELIABILITY AND SAFETY ISSUES WERE DETERMINED TO BE WITHIN ESTABLISHED FREQUENCY. A HEALTH HAZARD ASSESSMENT (HHA) DETERMINED A LOW HEALTH RISK, WHICH IS CONSISTENT WITH THE RISK MANAGEMENT FILE ASSOCIATED WITH THE PRODUCT ALTHOUGH, THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THERE EXIST A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE IF THE PRODUCT FAILS AT THE END OF ITS LIFE EXPECTANCY. THE WASTE OUTLET TUBE ASSEMBLY PART LIFE EXPECTANCY OF 2 YEARS IS NOT CURRENTLY IN OUR PRODUCT LABELING. THE PREVENTIVE ACTION WILL INVOLVE A LABEL CHANGE FOR THE WASTE OUTLET TUBE ASSEMBLY. WE ARE CHANGING OUR LABELING TO HAVE A PART REPLACEMENT SCHEDULE OF 6 MONTHS SO PARTS ARE REPLACED PRIOR TO THE END OF THE 2-YEAR LIFE FAILURE. THIS WILL HELP PREVENT OVERFLOW ISSUES CAUSED BY END OF LIFE PART FAILURE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT'S SON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2010. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED DURING THE FOLLOW-UP CALL, IN ADDITION TO THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S SON REPORTED THAT THE ALLEGED ISSUE BEGAN A COUPLE OF WEEKS PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED DATE/TIME, THE REPORTER CLAIMED THAT THE PATIENT OBTAINED AN ALLEGED INACCURATE RESULT OF "140 MG/DL" WITH THE SUBJECT METER. THE PATIENT'S SON STATED THAT THE PATIENT TESTS 2X/DAY (MORNING AND BEDTIME) AND MANAGES HIS DIABETES WITH A COMBINATION OF ORAL MEDICATION (GLIMEPIRIDE) AND INSULIN (UNKNOWN BRAND). THE REPORTER CLAIMED THAT THE PATIENT ONLY TAKES THE INSULIN IF HIS BLOOD GLUCOSE IS GREATER THAN "200 MG/DL." ON AN UNSPECIFIED DATE/TIME, AFTER THE ALLEGED INACCURACY STARTED, THE PATIENT'S SON REPORTED THAT HIS FATHER DEVELOPED SYMPTOMS OF FEELING SHAKY AND SWEATY. IN RESPONSE TO THE SYMPTOMS HE TREATED SELF WITH FOOD AND/OR DRINK. THE REPORTER DID NOT RECALL WHEN THE PATIENT HAD LAST TESTED OR WHAT BLOOD GLUCOSE READING WAS OBTAINED WITH THE SUBJECT METER PRIOR TO THE ONSET OF SYMPTOMS. IN ADDITION, THE REPORTER DID NOT RECALL IF THE PATIENT HAD TAKEN INSULIN (BASED ON A BLOOD GLUCOSE READING) PRIOR TO THE ONSET OF THE SYMPTOMS. THE PATIENT'S SON DID CONFIRM THAT AT THE ONSET OF SYMPTOMS HE TESTED HIS FATHER WITH BOTH THE SUBJECT METER AND ANOTHER DEVICE (REPORTER'S METER). THE PATIENT'S SON STATED THAT THE SUBJECT METER READ HIGHER THAN HIS METER; HOWEVER, DID NOT RECALL EITHER OF THE RESULTS OBTAINED ON THE DEVICES. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE REPORTER THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL OUTSIDE OF THE SPECIFIED CONTROL SOLUTION RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE WASTE SENSOR ON THE CELL-DYN 1800 ANALYZER IS NOT SENSING WASTE FULL CONDITIONS. WASTE HAS OVERFLOWED FROM THE WASTE CONTAINER ONTO THE FLOOR. THERE WERE NO INJURIES OR EXPOSURES REPORTED. THE CUSTOMER CLEANED THE SENSOR AND RESEATED ALL CONNECTIONS WITH NO RESOLUTION TO THE ISSUE. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE WILL SEND A NEW SENSOR TO THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 WASTE OUTLET TUBE LN: 92161-01| WASTE OUTLET TUBE LN: 92161-01| WASTE OUTLET TUBE LN: 92161-01| WASTE OUTLET TUBE LN: 92161-01| WASTE OUTLET TUBE LN: 92161-01