BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 3695717 · Received March 24, 2014

    Report

    Report Number
    3005248192-2014-00002
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF COMPLAINT INVESTIGATION FOR MDR 3005248192-2014-00002_FOLLOW-UP REPORT 1: PROBLEM: CUSTOMER REPORTED TO HAVE CUT HER HAND ON THE ROOF OF THE M2000SP CABINET NEAR THE WASTE CHUTE WHILE REPLACING THE SOLID WASTE CONTAINER. STAFF AT THE CUSTOMER SITE NOTICED AND PHOTOGRAPHED SPLASHES OF LIQUID AROUND ROOF OF THE CABINET AND DEDUCED THE SPLASHES WERE CRYSTALLIZED LYSIS BUFFER. CONCLUSION: RETAIN TESTING IS NOT APPLICABLE BECAUSE THIS IS A SERIALIZED DEVICE. RETURNS WERE NOT AVAILABLE FOR INVESTIGATION. COMPLAINT DESCRIPTION TEXT AND DETAILED FIELD SERVICE ENGINEER (FSE) INSPECTION RESULTS WERE USED TO EVALUATE THIS COMPLAINT TO DETERMINE IF THE CUT ON THE HAND OF THE OPERATOR WAS THE RESULT OF A PRODUCT DEFICIENCY. NO SHARP EDGES WERE FOUND ON THE CRYSTALLINE BUILDUP OF SPLASHES AS WELL AS INSIDE OF THE CABINET NEAR THE WASTE CHUTE DURING AN FSE SITE VISIT INSPECTION. PHOTOGRAPHS AND A DESCRIPTION OF THE FINDINGS WERE SENT BY THE FSE VIA EMAIL TO THE COMPLAINT INVESTIGATOR. MD0046 REVISION 35 - M2000 INSTRUMENT SYSTEM RISK ANALYSIS INDICATES RELEVANT HAZARDS OF "SHARP EDGES IN SAMPLE PREP INSTRUMENT". REVIEW INDICATES ALL HAZARDS ARE ADEQUATELY IDENTIFIED AND MITIGATED THROUGH ENGINEERING CONTROLS \ SAFETY CERTIFICATION, USE OF PERSONAL PROTECTION EQUIPMENT (LABCOAT, EYEWEAR, GLOVES, ETC.) AND LABELING (FOR WASTE REMOVAL). SHOULD A RECURRENCE OCCUR, THE SAME ENGINEERING CONTROLS TO PREVENT SHARP EDGES REMAIN IN PLACE. THEREFORE, THERE IS NO HAZARD ASSOCIATED WITH A RECURRENCE OF THIS ISSUE. CMSNEXT RECORDS FOR M2000SP SERIAL NUMBER (B)(4), WERE REVIEWED FOR OTHER POSSIBLY RELATED COMPLAINTS. NO OTHER INCIDENTS WERE FOUND. COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, THE SUSPECT (B)(4) WAS FOUND TO BE THE ONLY COMPLAINT RELATED TO INSTANCES OF A SKIN CUT DURING THE GENERAL USE OF THE M2000SP INSTRUMENT SYSTEM. THEREFORE, THERE IS AN OCCURRENCE RATE OF ONE OVER THE LAST TWO YEARS. BASED-UPON THE AVAILABLE INFORMATION, THE PRODUCT IS MEETING SPECIFICATIONS AND THIS COMPLAINT IS THEREFORE UNCONFIRMED.

    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. ACCIDENTAL EXPOSURE TO POTENTIALLY INFECTIOUS HUMAN SERUM/PLASMA OCCURRED WHEN A CUSTOMER SCRATCHED THE KNUCKLE OF HER HAND WHILE REPLACING THE SOLID WASTE CONTAINER ON AN ABBOTT M2000SP INSTRUMENT. THE LAB PERFORMS HIV, HCV AND HBV TESTING. THE CUSTOMER VISITED OCCUPATIONAL HEALTH WHERE THE EVENT WAS TREATED AS A "HIGH RISK NEEDLESTICK INJURY" AND WAS STARTED ON POSTEXPOSURE PROPHYLAXIS. IT IS UNKNOWN AT THIS TIME IF THE EVENT WAS CAUSED BY AN ABBOTT PRODUCT MALFUNCTION. AN ELEVATED INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171635 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other