BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2000SP INSTRUMENT E-SERIES

    MDR report key: 19656366 · Received July 2, 2024

    Report

    Report Number
    3005248192-2024-00114
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 20, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999031753
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    UPDATED B5 TO CORRECT PREP (PREEXPOSURE PROPHYLAXIS) TO PEP (POST-EXPOSURE PROPHYLAXIS). ALSO ADDED ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    ADDED ADDITIONAL INFORMATION RECEIVED TO SECTION B5. INVESTIGATION INTO THIS COMPLAINT INCLUDED A SUPPORTING INFORMATION REVIEW, QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: SUPPORTING INFORMATION REVIEW: THE M2000SP OPERATIONS MANUAL 200681-109-MARCH 2016, WAS REVIEWED. REVIEW CONCLUDED THE MANUAL CONTAINS: BIOSAFETY PROCEDURES AND BIOLOGICAL AND SAFETY WARNINGS ARE PROVIDED THROUGHOUT THE MANUAL. WARNINGS REGARDING THE RISK OF POTENTIALLY INFECTIOUS MATERIALS AND CAUTION TO UTILIZE APPROPRIATE BIOHAZARD PRECAUTIONS WERE FOUND IN THE DAILY MAINTENANCE SECTION. SECTION 8 CONTAINS GENERAL INFORMATION ABOUT BIOLOGICAL HAZARDS AND CHEMICAL HAZARDS. USE OF APPROPRIATE PPE (PERSONAL PROTECTIVE EQUIPMENT) WAS STRESSED. SECTION 8 ADDITIONAL HAS CLEANSING PROCEDURES FOR BIOHAZARDOUS EXPOSURE. QUALITY DATA REVIEW: A SEARCH OF NONCONFORMANCE AND CAPA RECORDS WAS PERFORMED FOR INSTANCES OF PERSONAL INJURY RELATED TO THE M2000SP INSTRUMENT BASE LIST NUMBER 09K14. THE QUERY FOR BASE 09K14 REVEALED NO RECORDS ASSOCIATED WITH BASE 9K14 AND THE REPORTED ISSUE. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED. COMPLAINT TRENDING WAS PERFORMED AND DID NOT IDENTIFY A TREND VIOLATION. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE M2000SP INSTRUMENT, LIST 09K14-02.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SERIOUS INJURY/ADVERSE EVENT OCCURRED ON THEIR M2000SP SYSTEM. THE CUSTOMER REPORTED THAT WHILE PERFORMING THE DAILY MAINTENANCE ON THEIR M2000SP, THE WASTE CHUTE FELL AND CUT THEIR FINGER. THE CUSTOMER CONFIRMED THAT THEY WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) (GLOVES, FACE MASK, LAB COAT, ETC.). THEY IMMEDIATELY WASHED THEIR HAND WITH TAP WATER. MEDICAL SERVICES WERE CONTACTED FOR TREATMENT OF THE INJURY AND FOR THE PREP (PREEXPOSURE PROPHYLAXIS) TREATMENT FOR HIV-1 ACCORDING TO THE COUNTRY REGULATIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SERIOUS INJURY/ADVERSE EVENT OCCURRED ON THEIR M2000SP SYSTEM. THE CUSTOMER REPORTED THAT WHILE PERFORMING THE DAILY MAINTENANCE ON THEIR M2000SP, THE WASTE CHUTE FELL AND CUT THEIR FINGER. THE CUSTOMER CONFIRMED THAT THEY WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) (GLOVES, FACE MASK, LAB COAT, ETC.). THEY IMMEDIATELY WASHED THEIR HAND WITH TAP WATER. MEDICAL SERVICES WERE CONTACTED FOR TREATMENT OF THE INJURY AND FOR THE PEP (POST-EXPOSURE PROPHYLAXIS) TREATMENT FOR HIV-1 ACCORDING TO THE COUNTRY REGULATIONS. ADDITIONAL INFORMATION RECEIVED ON JULY 2, 2024: THE LABORATORY MANAGER CONFIRMED THAT THE TECHNICIAN IS TAKING PEP (POST-EXPOSURE PROPHYLAXIS) AND THE MEDICATIONS PRESCRIBED ARE DOLUTEGRAVIR (50MG), LAMIVUDINE (300MG), AND TENOFOVIR DISOPROXIL FUMARATE TABLETS (300MG). THE TECHNICIAN IS CURRENTLY DOING FINE WITH NO COMPLAINTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SERIOUS INJURY/ADVERSE EVENT OCCURRED ON THEIR M2000SP SYSTEM. THE CUSTOMER REPORTED THAT WHILE PERFORMING THE DAILY MAINTENANCE ON THEIR M2000SP, THE WASTE CHUTE FELL AND CUT THEIR FINGER. THE CUSTOMER CONFIRMED THAT THEY WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) (GLOVES, FACE MASK, LAB COAT, ETC.). THEY IMMEDIATELY WASHED THEIR HAND WITH TAP WATER. MEDICAL SERVICES WERE CONTACTED FOR TREATMENT OF THE INJURY AND FOR THE PEP (POST-EXPOSURE PROPHYLAXIS) TREATMENT FOR HIV-1 ACCORDING TO THE COUNTRY REGULATIONS. ADDITIONAL INFORMATION RECEIVED ON JULY 2, 2024: THE LABORATORY MANAGER CONFIRMED THAT THE TECHNICIAN IS TAKING PEP (POST-EXPOSURE PROPHYLAXIS) AND THE MEDICATIONS PRESCRIBED ARE DOLUTEGRAVIR (50MG), LAMIVUDINE (300MG), AND TENOFOVIR DISOPROXIL FUMARATE TABLETS (300MG). THE TECHNICIAN IS CURRENTLY DOING FINE WITH NO COMPLAINTS. ADDITIONAL INFORMATION RECEIVED ON AUGUST 19, 2024: THE CUSTOMER CONFIRMED THAT THE AFFECTED TECHNICIAN FINISHED THE PEP (POST-EXPOSURE PROPHYLAXIS) AND TESTED FOR HIV-1 AND THE RESULT WAS NOT REACTIVE. THE TECHNICIAN IS CURRENTLY FEELING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757552 M2000SP INSTRUMENT E-SERIES REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999031753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention