BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 1082239 · Received July 23, 2008

    Report

    Report Number
    1628664-2008-00178
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    K897158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (INVESTIGATION IS IN PROCESS, NO CONCLUSION CAN BE DRAWN). 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). ISSUE WAS IDENTIFIED AS AGE AND USE OF THE INSTRUMENT. NO PRODUCT DEFICIENCY WAS IDENTIFIED. INVESTIGATION RESULTS: THE BROKEN HINGES HAVE BEEN ATTRIBUTED TO THE AGE OF THE INSTRUMENT. THE INSTRUMENT HAS BEEN IN THE ACCOUNT SINCE 1998. FIELD SERVICE REPLACED THE RIGHT FRONT PANEL HINGES AND THE LEFT LID HINGE. ALL SPECIFICATIONS WERE MET AND THE KEYPAD WAS VERIFIED TO BE FUNCTIONAL. A REVIEW OF THE CUSTOMER HISTORY FOR THE (B) (4), LIST 6208-01, SERIAL (B) (4) FOR A TIME PERIOD OF (B) (6) 2008 TO (B) (6) 2008 WAS PERFORMED. THE RESULTS OF THE REVIEW DID NOT FIND OTHER COMPLAINTS DUE TO ISSUES RELATED TO BROKEN HINGES AND/OR POTENTIAL INJURIES CAUSED BY BROKEN HINGES. A REVIEW OF TRACKING AND TRENDING FOUND NO OTHER COMPLAINTS FOR THE ISSUE RELATED TO BROKEN HINGES, POTENTIAL INJURIES CAUSED BY BROKEN HINGES FOR THE (B) (6). THE (B) (6) OPERATIONS MANUAL DESCRIBES THE FOLLOWING RELATED TO THE CUSTOMER'S ISSUE: SECTION 7 OPERATION PRECAUTIONS AND LIMITATIONS - GENERAL ALL COVERS SHOULD BE CLOSED AND IN PLACE WHEN RUNNING ASSAYS. PROPER MAINTENANCE OF THE PPC SHOULD BE FOLLOWED AS DESCRIBED IN SECTION 9, SERVICE AND MAINTENANCE. TURN OFF POWER AND UNPLUG UNIT BEFORE WORKING INSIDE THE INSTRUMENT. USE OF DIAGNOSTICS CAUSES THE SYSTEM TO REST. DATA ON TRAYS IN PROCESS (I.E.,, WHICH HAVE BEEN IDENTIFIED WITH A TRAY ID AND HAVE NOT BEEN PHYSICALLY REMOVED FROM THE INSTRUMENT) WILL BE LOST. SECTION 8 HAZARDS - OVERVIEW: THIS SECTION PROVIDES INFORMATION REGARDING HAZARDS THAT MIGHT BE ENCOUNTERED WHILE OPERATING THE (B) (6). WHILE THE PPC IS DESIGNED TO MINIMIZE HAZARDS, SOME ARE INHERENT TO THE OPERATION OF AN ELECTROMECHANICAL INSTRUMENT. ADDITIONALLY, THE BEAD ENZYME IMMUNOASSAYS PROCESSED ON THE PPC PRESENT POTENTIAL ASSAY-SPECIFIC HAZARDS. THEREFORE, OPERATORS MUST PERFORM ALL WORK IN ACCORDANCE WITH PROCEDURES DESCRIBED IN THE OPERATIONS MANUAL OR AS DIRECTED BY ABBOTT LABORATORIES, AND OPERATORS MUST CONSIDER SAFETY AWARENESS VERY IMPORTANT. FAILURE TO TAKE PRECAUTIONS TO AVOID THE FOLLOWING HAZARDS COULD RESULT IN PERSONAL INJURY OR DAMAGE TO THE LABORATORY. THIS SECTION CLEARLY DEFINES THESE HAZARDS AND PROVIDES INSTRUCTIONS FOR THE PREVENTION OF AND RESPONSE TO SPECIFIED HAZARDS. THE FOLLOWING TOPICS ARE DISCUSSED IN THIS SECTION: BIOLOGICAL HAZARDS. ELECTRICAL SAFETY. ELECTRICAL HAZARDS. PHYSICAL AND MECHANICAL SAFETY. PHYSICAL AND MECHANICAL HAZARDS. CHEMICAL SAFETY. CHEMICAL HAZARDS. PHYSICAL AND MECHANICAL SAFETY: BASIC RULES OF MECHANICAL OPERATION ARE ESSENTIAL TO SAFE OPERATION OF THE PPC. OPERATORS SHOULD PRACTICE FOUND MECHANICAL SAFETY HABITS THAT INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: KEEP ALL PROTECTIVE COVERS IN PLACE WHEN PROCESSING SPECIMENS. VERIFY THAT ALL COVERS ARE SECURELY OPEN TO PREVENT INADVERTENT CLOSURE. USE CARE WHEN CLOSING COVERS SO AS NOT TO PINCH HANDS OR FINGERS. DO NOT ALLOW ANY BODY PARTS TO ENTER THE RANGE OF MECHANICAL MOVEMENT DURING PPC OPERATION. DO NOT WEAR CLOTHING OR ACCESSORIES THAT COULD BE CAUGHT IN THE PPC. KEEP POCKETS FREE OF ANYTHING THAT COULD FALL INTO THE PPC. USE PROPER PRECAUTIONS AND LIFTING TECHNIQUES WHEN MOVING OR TRANSPORTING THE PPC. ALLOW ENOUGH TIME TO COMPLETE ALL PROCEDURES CORRECTLY. NOTE: BE ESPECIALLY CAUTIOUS WHEN PERFORMING SERVICE OR MAINTENANCE PROCEDURES. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE COMMANDER PPC RIGHT FRONT PANEL HINGES SNAPPED OFF AND WAS HANGING BY THE CABLE. THE ACCOUNT STATED THE LEFT LID HINGE IS ALSO BROKEN. SVC REPLACED THE COMMANDER PPC HINGE KIT AND DOOR HINGE WITH KEYPAD. NO OPERATORS WERE INJURED DUE TO THE BROKEN HINGES.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA