BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 4208194 · Received October 28, 2014

    Report

    Report Number
    3005248192-2014-00069
    Event Type
    Injury
    Date Received
    October 28, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ELEVATED COMPLAINT INVESTIGATION 4233-ECINV SUMMARY: INVESTIGATION INTO THIS COMPLAINT INCLUDED A QUALITY DATA REVIEW, A PRODUCT EVALUATION, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW: A REVIEW OF THE M2000SP OPERATIONS MANUAL 200681-107-JULY 2013 VERIFIED THAT THE M2000SP OPERATIONS MANUAL 200681--107-JULY 2013 CONTAINS INFORMATION ON HOW TO SAFELY EMPTY THE LIQUID WASTE CONTAINED AS WELL AS INFORMATION ON THE HAZARD ASSOCIATED WITH THE LIQUID WASTE. A REVIEW OF INCIDENT REPORTS BY ABBOTT MOLECULAR EHS (EMPLOYEE HEALTH AND SAFETY) DEPARTMENT DID NOT IDENTIFY ANY INJURIES OR CHEMICAL EXPOSURES THAT WERE THE RESULT OF AN EMPLOYEE REMOVING WASTE FROM THE M2000SP ANALYZER. PRODUCT EVALUATION: RETAIN TESTING WAS NOT APPLICABLE AS THE M2000SP INSTRUMENT SYSTEM IS A SERIALIZED DEVICE. RETURN OF THE INSTRUMENT WAS NOT REQUIRED AS THERE WAS NO ALLEGED PRODUCT DEFICIENCY. THE ACTIVITY TAB TEXT OF THE COMPLAINT INDICATED THE SPLASH OCCURRED WHILE EMPTYING LIQUID WASTE INTO A SINK. THE CUSTOMER SITE WAS SEEKING ADVICE FOR THE RISK OF INFECTION TO THE OPERATOR. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, THIS COMPLAINT (B)(4) WAS THE ONLY COMPLAINT IDENTIFIED OF AN OPERATOR BEING SPLASHED IN THE EYE WHILE ATTEMPTING TO EMPTY THE LIQUID WASTE. PRODUCT DEFICIENCY DECISION: BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE M2000SP INSTRUMENT SYSTEM (09K14-02) AND WAS NOT IDENTIFIED.

    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. WHILE PERFORMING MAINTENANCE ON AN M2000SP INSTRUMENT SYSTEM, LIQUID WASTE SPLASHED INTO THE EYE OF AN INSTRUMENT OPERATOR AS SHE WAS POURING THE LIQUID WASTE INTO A SINK. THIS COULD RESULT IN SERIOUS INJURY AS THE WASTE IS POTENTIALLY INFECTIOUS. THE USER WAS WEARING PROTECTIVE GLOVES AND LAB COAT, BUT WAS WEARING PERSONAL EYEWEAR AND NOT PROTECTIVE EYEWEAR. THE USER WAS GIVEN A MEDICAL CHECKUP; BLOOD SAMPLES WERE TAKEN AND THE USER WILL BE MONITORED AGAIN IN TWO MONTHS. ELEVATED COMPLAINT INVESTIGATION (ECINV) WAS OPENED. BASED ON THE RESULTS OF THE INVESTIGATION A PRODUCT DEFICIENCY FOR THE M2000SP INSTRUMENT SYSTEM WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690489 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other