BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW PBP2A SA CULTURE COLONY TEST

    MDR report key: 17566033 · Received August 17, 2023

    Report

    Report Number
    1221359-2023-01335
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 6, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MYI
    UDI-DI
    10811877011238
    PMA / PMN Number
    K133851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 234603W WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 893-000 / LOT 234603W. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS STRUCTURAL ISSUES (PACKAGING) (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 234603W SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.H6: MEDICAL DEVICE PROBLEM CODE, D4 - UNIQUE IDENTIFIER (UDI) # H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) REAGENT AND SAMPLE EXPOSURE TO THE SKIN WITH THE CLEARVIEW PBP2A SA CULTURE COLONY TEST PERFORMED ON (B)(6) 2023.THIS MFR. REPORT ADDRESSES EVENT TWO (2) OF TWO (2). PER THE CUSTOMER, THE TUBE HOLDING THE REAGENT AND SAMPLE "SELF-EJECTED" FROM THE SUPPORT TRAY, WHICH CAUSED THE SAMPLE AND REAGENT OF THE CLEARVIEW PBP2A SA CULTURE COLONY TEST TO SPLASH ONTO THE COUNTERTOP AND ONTO THE INTACT SKIN OF THE LAB TECHNICIAN. THE TRAY WAS ON A FLAT STERILE SURFACE. THE CUSTOMER STATED AN ALLERGIC TEST WAS NOT INITIATED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE EXPOSURE. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) REAGENT AND SAMPLE EXPOSURE TO THE SKIN WITH THE CLEARVIEW PBP2A SA CULTURE COLONY TEST PERFORMED ON (B)(6) 2023.THIS MFR. REPORT ADDRESSES EVENT TWO (2) OF TWO (2). PER THE CUSTOMER, THE TUBE HOLDING THE REAGENT AND SAMPLE "SELF-EJECTED" FROM THE SUPPORT TRAY, WHICH CAUSED THE SAMPLE AND REAGENT OF THE CLEARVIEW PBP2A SA CULTURE COLONY TEST TO SPLASH ONTO THE COUNTERTOP AND ONTO THE INTACT SKIN OF THE LAB TECHNICIAN. THE TRAY WAS ON A FLAT STERILE SURFACE. THE CUSTOMER STATED AN ALLERGIC TEST WAS NOT INITIATED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE EXPOSURE. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) REAGENT AND SAMPLE EXPOSURE TO THE SKIN WITH THE CLEARVIEW PBP2A SA CULTURE COLONY TEST PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES EVENT TWO (2) OF TWO (2). PER THE CUSTOMER, THE TUBE HOLDING THE REAGENT AND SAMPLE "SELF-EJECTED" FROM THE SUPPORT TRAY, WHICH CAUSED THE SAMPLE AND REAGENT OF THE CLEARVIEW PBP2A SA CULTURE COLONY TEST TO SPLASH ONTO THE COUNTERTOP AND ONTO THE INTACT SKIN OF THE LAB TECHNICIAN. THE TRAY WAS ON A FLAT STERILE SURFACE. THE CUSTOMER STATED AN ALLERGIC TEST WAS NOT INITIATED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE EXPOSURE. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994152 CLEARVIEW PBP2A SA CULTURE COLONY TEST SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, STAPHYLOCOCCUS COLONIES MYI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 234603W 10811877011238

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other