BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 779920 · Received November 9, 2006

    Report

    Report Number
    1628664-2006-00087
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    October 27, 2006
    Report Date
    October 27, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JQW
    PMA / PMN Number
    k897158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE INCIDENT TO THEIR EMPLOYEE HEALTH DEPT AND RECEIVED A TETANUS SHOT AS A PRECAUTION AND THE CUSTOMER WAS ALSO DUE TO RECEIVE THE VACCINE. AN EXPOSURE REPORT WAS NOT CREATED AT THE FACILITY. THERE WAS NO FURTHER TREATMENT AND FOLLOWUP DETERMINED THE CUSTOMER TO BE FINE. THE CUSTOMER STATED THEY KNEW NOT TO HAVE THEIR HAND IN THE INSTRUMENT WHEN POWERING UP AND THE INSTRUMENT WAS INITIALIZING. FIELD SERVICE VISITED THE ACCOUNT TO RESOLVE CLICKING NOISES HEARD. A MULTI-POINT INSPECTION WAS PERFORMED AND THE INSTRUMENT WAS RETURNED TO THE CUSTOMER OPERATIONAL. SERVICE HISTORY REVIEW FOR THE TIME PERIOD OF 10/01/2005 THROUGH 11/01/2006 INDICATES THERE HAVE BEEN NO OTHER COMPLAINTS FOR POTENTIAL INJURY. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PPC PASSED ALL MANUFACTURING REQUIREMENTS AND WAS RELEASED FOR DISTRIBUTION ON 07/18/1996. THERE WAS NO DEFICIENCY FOUND DURING THE TRENDING REVIEW (SEPT 2006) CONCERNING THE PPC SYSTEM THAT WOULD SUGGEST THAT THE USE OF THIS PRODUCT WOULD CAUSE SOME TYPE OF ADVERSE HEALTH CONSEQUENCE OR THAT THE PRODUCT IS PERFORMING CONTRARY TO INTENDED USE OR LABEL CLAIMS. OPERATOR ERROR IS THE MOST PROBABLE CAUSE FOR THE INJURY. THE OPERATOR DID NOT FOLLOW FSR INSTRUCTIONS OR THE LABELING IN THE OPERATIONS MANUAL IN ORDER TO PREVENT AN INJURY. LABELING: PPC SYSTEM OPERATION MANUAL (LN#1A05-57) SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS, STATES ALL COVERS SHOULD BE CLOSED AND IN PLACE WHEN RUNNING. THE POWER SHOULD BE TURNED OFF AND THE UNIT UNPLUGGED BEFORE WORKING INSIDE THE INSTRUMENT. AN EMERGENCY STOP PROCEDURE IS PROVIDED. SECTION 8, HAZARDS, WARNS OF POTENTIAL BIOHAZARD THAT MIGHT BE ENCOUNTERED WHILE OPERATING THE PPC. BIOLOGICAL HAZARDS: CONSIDER ALL SPECIMENS, CONTROLS, CALIBRATORS, SURFACES, WASTE OR COMPONENTS AS POTENTIALLY INFECTIOUS. WEAR GLOVES, A LAB COAT AND PROTECTIVE EYEWEAR WHEN OPERATING OR MAINTAINING THE PPC. OBSERVE OTHER BIOSAFETY PRACTICES AS SPECIFIED IN THE OSHA BLOODBORNE PATHOGEN RULE (29 CFR PART 1910.1030) OR OTHER EQUIVALENT BIOSAFETY PROCEDURES. PHYSICAL AND MECHANICAL SAFETY: DO NOT ALLOW ANY BODY PARTS TO ENTER THE RANGE OF MECHANICAL MOVEMENT DURING PPC OPERATION. SECTION 9, SERVICE AND MAINTENANCE, TRANSPORT SYSTEM MAINTENANCE STATES THE TRANSPORT TRACK SHOULD BE WIPED DOWN ONCE A WEEK WITH A SOFT CLOTH OR SWAB DAMPENED WITH ISOPROPYL ALCOHOL. SPILLS SHOULD BE CLEANED IMMEDIATELY. A WARNING STATES TO TURN OFF THE INSTRUMENT AND UNPLUG POWER CORD BEFORE OPENING THE INSTRUMENT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    AN ABBOTT FIELD SERVICE REP (FSR) WAS ASSISTING THE CUSTOMER VIA TELEPHONE IN CLEANING A SPILL ON THE COMMANDER PPC AUGER. THE FSR INSTRUCTED THE CUSTOMER TO POWER OFF THE PPC PRIOR TO CLEANING THE AUGER. THE CUSTOMER HAD THEIR HAND IN THE PPC WHEN THEY POWERED UP THE ANALYZER. THE AUGERS MOVED UPON INITIALIZATION AND CAUGHT AND TORE THE GLOVE AND CUT THE TIP OF THE CUSTOMER'S RIGHT INDEX FINGER. THE OPERATOR REPORTED THE INCIDENT TO THEIR EMPLOYEE HEALTH DEPT AND RECEIVED A TETANUS SHOT AS A PRECAUTION. THERE WAS NO FURTHER TREATMENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS JQW ABBOTT MANUFACTURING, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention