BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP INSTRUMENT

    MDR report key: 7825190 · Received August 28, 2018

    Report

    Report Number
    3005248192-2018-00010
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    August 16, 2018
    Report Date
    September 25, 2018
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    UDI-DI
    00884999031753
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED AN EXISTING DATA REVIEW, A QUALITY DATA REVIEW, A COMPLAINT HISTORY REVIEW AND A PRODUCT/SYSTEM/INSTRUMENT EVALUATION. INVESTIGATION IS SUMMARIZED AS FOLLOWS: EXISTING DATA REVIEW: REVIEW OF THE M2000SP OPERATIONS MANUAL LIST 9K20-009, 200681-109 MARCH 2016, IDENTIFIED THAT PERSONAL INJURY DESCRIBED IN THIS COMPLAINT WERE THE DIRECT RESULT OF CUSTOMER USE OUTSIDE OF INSTRUMENT INSTRUCTIONS. THE OPERATOR DID NOT REMOVE THE AMPLIFICATION REAGENT PACKS FROM THE INSTRUMENT AS DIRECTED IN THE OPERATIONS MANUAL, WHICH INSTRUCTS THE OPERATOR TO UNLOAD THE AMPLIFICATION REAGENT PACKS AFTER FIRST REMOVING THE ASSAY REAGENT HOLDER FROM THE INSTRUMENT. IN ADDITION, THE CUSTOMER ATTEMPTED TO CLEAN THE ROMA GRIPPER FINGER RESULTING IN ANOTHER INJURY. REVIEW OF APPLICABLE LABELING VERIFIED THAT THERE ARE NO INSTRUCTIONS TO CLEAN OR MAINTAIN THE ROMA GRIPPER FINGERS. QUALITY DATA REVIEW: NO RELATED NONCONFORMANCES OR CAPA RECORDS WERE FOUND RELATED TO SHARP EDGES RELATED TO THE ROMA GRIPPER FINGERS OF THE M2000SP INSTRUMENT. COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, NO OTHER RELATED COMPLAINTS WERE IDENTIFIED. ADDITIONALLY, NO RELATED NONCONFORMANCES OR CAPA RECORDS WERE FOUND RELATED TO THE LOT OF THE PLASTIC REAGENT PACK COMMODITY USED DURING THE COMPLAINT RUN. COMPLAINT HISTORY REVIEW SHOWED THAT NO OTHER COMPLAINTS WERE IDENTIFIED RELATED TO REAGENT PACK FITMENT ISSUES. SERVICE HISTORY REVIEW: REVEALED M2000SP SN10474 WAS INSTALLED AT THE COMPLAINT CUSTOMER SITE IN BOGOTA, COLOMBIA IN APRIL 2012. NO ADDITIONAL SERVICE TICKETS WERE IDENTIFIED RELATED TO PERSONAL INJURIES OR ANY REPORTS OF SHARP EDGES ON THIS INSTRUMENT. RETAIN SAMPLE EVALUATION: REPLACEMENT SPARE PARTS ARE NOT RETAINED FOR THE M2000SP E-SERIES INSTRUMENT AS IT IS A SERIALIZED DEVICE. RETAINS OF THE AMPLIFICATION PACK USED AT THE TIME OF THE REPORTED INJURIES WERE NOT EVALUATED AS ALL OTHER ELEMENTS OF THIS INVESTIGATION DO NOT INDICATE ANY SYSTEMIC PRODUCT DEFICIENCY WITH THE PLASTIC REAGENT PACK USED TO MANUFACTURE THIS PART. RETURN SAMPLE EVALUATION: THE ROMA GRIPPER FINGERS ASSOCIATED WITH THE TICKET UNDER INVESTIGATION WERE RETURNED TO ABBOTT MOLECULAR FOR EVALUATION. MEASUREMENTS ON BOTH ENDS OF THE SECTION OF THE GRIPPER ARMS REPORTED TO CAUSE INJURY VERIFIED THAT THE PART REMAINED WITHIN SPECIFICATION TOLERANCES. TESTING PER UL1439 ONLY INDENTED THE TEST TAPE, MEANING NO SHARP EDGE PER IEC 61010-1 WAS PRESENT. RETURNS OF THE RELEVANT REAGENT PACK WERE NOT AVAILABLE. ENGINEERING EVALUATION - SAFETY ASSESSMENT PER THE APPLICABLE SECTIONS OF IEC 61010-1 SAFETY STANDARD, SECTION 7 CONTAINS GENERAL REQUIREMENTS FOR SHARP EDGES: ALL EASILY-TOUCHED PARTS OF THE EQUIPMENT SHALL BE SMOOTH AND ROUNDED SO AS NOT TO CAUSE INJURY DURING NORMAL USE. REVIEW OF ENGINEERING DRAWINGS FOR THE ROMA GRIPPER ARMS IDENTIFIED THAT BY DESIGN SHARP EDGES ARE REMOVED, ALL BURS ARE TO BE REMOVED, AND ALL EXTERNAL CORNERS ARE ROUNDED. IN-HOUSE TESTING ON FIVE M2000SP INSTRUMENTS DEMONSTRATED THE ROMA GRIPPER FINGERS DID NOT CUT THE OUTER SENSING TAPE, MEANING NO INJURY WOULD RESULT FROM CONTACT WITH A FINGER. BASED ON THE RESULTS OF INVESTIGATION, NO PRODUCT DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. THE CUSTOMER STATES THAT THEIR MASTER MIX ADDITION RUN FOR HIV-1 ROUTINE ENDED NORMALLY. THE CUSTOMER TRIED TO LIFT THE AMPLIFICATION REAGENT PACKS FROM THE ASSAY REAGENT HOLDER ON THE OUTPUT DECK OF THE M2000SP INSTRUMENT TO DISCARD THEM, BUT THE PACKS DIDN'T COME OUT EASILY, SO THE CUSTOMER APPLIED MORE FORCE TO DO SO. AT ONE TIME WHILE LIFTING, THE CUSTOMER COULDN´T TAKE THE AMPLIFICATION PACK, AND HER HAND CRASHED WITH THE ROBOTIC MANIPULATOR ARM (ROMA), RESULTING IN TEARING OF THE GLOVE AND A CUT ON THE KNUCKLES WITH BLOOD. AFTER THAT, THE CUSTOMER TRIED TO CLEAN THE BLOOD FROM THE ARM, BUT SHE CUT HER INDEX FINGER (WHILE USING GLOVES), REPORTING THE EDGE OF THE ARM IS SHARP. THE CUSTOMER WASHED HER INJURIES FOR 30 MINUTES WITH WATER AND SOAP. CUSTOMER STATED SHE WENT TO THE PHYSICIAN AFTER THE ACCIDENT. SHE WAS TESTED FOR HIV-1, HCV AND HBV; RESULTS WERE NEGATIVE. SHE WAS VACCINATED AGAINST TETANUS AND IS UNDER ANTIRETROVIRAL TREATMENT FOR 1 MONTH. CLARIFICATION RECEIVED (B)(6), 2018 THAT USER MEDICAL TREATMENT INCLUDED LAMIVUDINA ZIDOVUDINA AND LOPINAVIR + RITONAVIR. NO PATIENT WAS INVOLVED, INJURY WAS SUSTAINED BY AN ABBOTT M2000SP INSTRUMENT USER. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN COLOMBIA USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02, WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    AN ELEVATED COMPLAINT INVESTIGATION WILL BE PERFORMED. H4 WILL BE PROVIDED WITH THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. THE CUSTOMER STATES THAT THEIR MASTER MIX ADDITION RUN FOR HIV-1 ROUTINE ENDED NORMALLY. THE CUSTOMER TRIED TO LIFT THE AMPLIFICATION REAGENT PACKS FROM THE ASSAY REAGENT HOLDER ON THE OUTPUT DECK OF THE M2000SP INSTRUMENT TO DISCARD THEM, BUT THE PACKS DIDN'T COME OUT EASILY, SO THE CUSTOMER APPLIED MORE FORCE TO DO SO. AT ONE TIME WHILE LIFTING, THE CUSTOMER COULDN´T TAKE THE AMPLIFICATION PACK, AND HER HAND CRASHED WITH THE ROBOTIC MANIPULATOR ARM, RESULTING IN TEARING OF THE GLOVE AND A CUT ON THE KNUCKLES WITH BLOOD. AFTER THAT, THE CUSTOMER TRIED TO CLEAN THE BLOOD FROM THE ARM, BUT SHE CUT HER INDEX FINGER (WHILE USING GLOVES), REPORTING THE EDGE OF THE ARM IS SHARP. THE CUSTOMER WASHED HER INJURIES FOR 30 MINUTES WITH WATER AND SOAP. CUSTOMER STATED SHE WENT TO THE PHYSICIAN AFTER THE ACCIDENT. SHE WAS TESTED FOR HIV-1, HCV AND HBV; RESULTS WERE NEGATIVE. SHE WAS VACCINATED AGAINST TETANUS AND IS UNDER ANTIRETROVIRAL TREATMENT FOR 1 MONTH. NO PATIENT WAS INVOLVED, INJURY WAS SUSTAINED BY AN ABBOTT M2000SP INSTRUMENT USER. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN COLOMBIA USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02, WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663727 ABBOTT M2000SP INSTRUMENT CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC. 00884999031753

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other