BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 3985619 · Received August 6, 2014

    Report

    Report Number
    3005248192-2014-00006
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR ESCALATED COMPLAINT INVESTIGATION FINAL REPORT SUMMARY FOR MDR 3005248192-2014-00006: THE CABINET WAS INSPECTED BY AN ABBOTT FIELD SERVICE ENGINEER (FSE) DURING A SPECIAL ON-SITE VISIT. NO SHARP EDGES OR ISSUES WERE FOUND. IN ADDITION TO INSPECTION, THE FSE HAD A CONVERSATION WITH THE SITE SAFETY OFFICER, WHO SUMMARIZED THE ACCIDENT REPORT AND STATED THAT THE TECHNICIAN WAS IN A HURRY EMPTYING THE WASTE BOTTLE WHEN SHE CAUGHT HER FOOT UNDER THE CORNER OF THE DRAWER AS SHE WAS HEADING TO THE SINK. A FOLLOW-UP TELEPHONE INTERVIEW WITH THE SITE SAFETY OFFICER ESTABLISHED THE INJURY WAS A SLIGHT PUNCTURE WOUND THAT DID NOT BLEED ON THE OUTSIDE OF THE RIGHT ANKLE WHILE THE TECHNICIAN WAS CHANGING THE SYSTEM LIQUID. THE SAFETY OFFICER DID NOT CONSIDER THE INCIDENT TO BE A SAFETY ISSUE WITH THE M2000SP INSTRUMENT. THE M2000SP OPERATIONS MANUAL CONTAINS ADEQUATE INFORMATION IN REGARD TO DEFINITION, LOCATION, FILLING AND CLEANING OF THE SYSTEM LIQUID CONTAINER. SERVICE RECORDS FOR M2000SP SERIAL NUMBER (B)(4) WERE REVIEWED FOR OTHER POSSIBLY RELATED COMPLAINTS. NO OTHER INCIDENTS WERE FOUND. THE M2000SP INSTRUMENT SYSTEM RISK ANALYSIS INDICATES RELEVANT HAZARDS OF SHARP EDGES IN THE SAMPLE PREPARATION INSTRUMENT. REVIEW INDICATES ALL HAZARDS ARE ADEQUATELY IDENTIFIED AND MITIGATED THROUGH ENGINEERING CONTROLS, SAFETY CERTIFICATION, USE OF PPE AND LABELING (FOR WASTE REMOVAL). THEREFORE, THERE IS NO HAZARD ASSOCIATED WITH A RECURRENCE OF THIS ISSUE BECAUSE ENGINEERING CONTROLS THAT PREVENT SHARP EDGES REMAIN IN PLACE AT THE SUSPECT SITE. COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, THE SUSPECT COMPLAINT ((B)((4) (INVESTIGATED AS (B)(4) FOR A CUT TO THE HAND FROM THE WASTE CHUTE) WERE FOUND TO BE THE ONLY COMPLAINTS RELATED TO OPERATOR INJURY FROM THE M2000SP INSTRUMENT CABINET. THEREFORE, THERE IS AN OCCURRENCE RATE OF TWO OVER THE LAST TWO YEARS. BASED-UPON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE OF A PRODUCT DEFICIENCY. THE M2000SP IS MEETING SPECIFICATIONS.

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID AMPLIFICATION TESTING BY POLYMERASE CHAIN REACTION IN CLINICAL LABORATORIES. THE SYSTEM IS COMPOSED OF THE M2000RT AND THE M2000SP INSTRUMENTS. THE M2000SP IS INTENDED FOR AUTOMATED SAMPLE PREPARATION AND NUCLEIC ACID EXTRACTION PRIOR TO TESTING. DURING A (B)(6) 2014 SITE VISIT TO A CUSTOMER REFERENCE LAB, AN ABBOTT MOLECULAR APPLICATION SPECIALIST (MAS) BECAME AWARE THAT AN INSTRUMENT OPERATOR TECHNICIAN WAS INJURED ON (B)(6) 2014. THE TECHNICIAN EXPLAINED SHE BACKED INTO THE METAL CORNER OF THE DRAWER ON THE M2000SP INSTRUMENT WHILE CHANGING THE SYSTEM FLUID AND OBTAINED A PUNCTURE WOUND AND BRUISE. SHE INFORMED HER SUPERVISOR AND QUALITY SYSTEMS/SAFETY REPRESENTATIVE ON (B)(6) 2014. THE TECHNICIAN EXPLAINED THAT THE WOUND DID NOT REQUIRE SUTURES AND THAT SHE IS BEING MONITORED FOR INFECTIOUS DISEASE DUE TO POTENTIAL EXPOSURE TO HIV, HCV AND HBV. A FOLLOW-UP TELEPHONE INTERVIEW WITH THE SITE SAFETY OFFICER ESTABLISHED THE INJURY WAS A SLIGHT PUNCTURE WOUND THAT DID NOT BLEED ON THE OUTSIDE OF THE RIGHT ANKLE WHILE THE TECHNICIAN WAS CHANGING THE SYSTEM LIQUID. THE WASTE TRAY WITHIN THE M2000SP CABINET MAY CONTAIN HUMAN SERUM AND OR PLASMA WHICH ARE CLASSIFIED AS POTENTIALLY INFECTIOUS. THE USER MAY BE EXPOSED TO COMPONENTS CONTAINING POTENTIALLY INFECTIOUS HUMAN SERUM/PLASMA. NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN SOURCES WILL NOT TRANSMIT INFECTION. EXPOSURE MAY LEAD TO INFECTION AND ITS CONSEQUENCES. ABBOTT MOLECULAR OPENED ESCALATED COMPLAINT INVESTIGATION NUMBER (B)(4) TO INVESTIGATE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462101 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other