BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA VAGINAL SPECIMEN COLLECTION KIT

    MDR report key: 1733170 · Received June 15, 2010

    Report

    Report Number
    2024800-2010-00002
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    February 1, 2009
    Report Date
    June 15, 2010
    Manufacturer
    GEN-PROBE, INC.
    Product Code
    LSL
    PMA / PMN Number
    K032554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    ON MAY 17, 2010, GEN-PROBE SALES STAFF REC'D SECOND HAND INFO FROM AN EMPLOYEE OF A PUBLIC HEALTH CLINIC THAT THERE WAS AN INCIDENT AT ANOTHER INSTITUTION IN WHICH A VAGINAL SWAB BROKE WHILE THE PT WAS COLLECTING A SPECIMEN. GEN-PROBE WAS ABLE TO TRACK BACK TO DR (B)(6) WHO CONFIRMED THIS INFO AND STATED THAT A NURSE PRACTITIONER REMOVED THE SWAB FROM THE PT. SHE BELIEVED THE PT HAD HELD THE SHAFT AT A POINT CLOSER TO THE END AWAY FROM THE SWAB HEAD ALTHOUGH STEP 3 OF PRODUCT INSTRUCTION FOR THE COLLECTION KIT STATES: "HOLD THE SWAB IN YOUR HAND AS SHOWN IN DIAGRAM 2, PLACING YOUR THUMB AND FOREFINGER IN THE MIDDLE OF THE SWAB SHAFT." DR (B)(6) RECALLED THAT THE SWAB WAS LODGED AND PAINFUL FOR THE PT. PER DR (B)(6), THE INCIDENT OCCURRED BETWEEN (B)(6) 2009, BUT SHE COULD NOT PROVIDE THE SPECIFIC DATE OF INCIDENT OR NAME OF THE PT. DR (B)(6) ALSO INDICATED THAT A SIMILAR INCIDENT HAD HAPPENED SEVERAL TIMES IN THE PAST BUT ONLY THIS SPECIFIC INCIDENT REQUIRED THE SWAB SHAFT TO BE RETRIEVED FROM THE VAGINA USING A SPECULUM. NONE OF THESE INCIDENTS WERE REPORTED TO GEN-PROBE OR FILED VIA FDA FORM 3500A AT THE TIME WHEN THEY HAPPENED SO SPECIFIC LOT# AND PT INFO ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APTIMA VAGINAL SPECIMEN COLLECTION KIT LSL, MKZ LSL GEN-PROBE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention