BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGENE HC2 DNA COLLECTION DEVICE

    MDR report key: 5525064 · Received March 24, 2016

    Report

    Report Number
    1122376-2016-00011
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    March 23, 2015
    Report Date
    March 24, 2016
    Manufacturer
    QIAGEN
    Product Code
    HHT
    PMA / PMN Number
    K971586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 INCIDENT REPORTED TO QIAGEN TECHNICAL SERVICE. ON (B)(4) 2015 INCIDENT DATE AND DETAILS AND DEFECTIVE DEVICE REQUIRED. ON (B)(4) 2015 CUSTOMER REPORTED THE INCIDENT OCCURRED. ON (B)(6) 2015 AND DEVICE WAS REMOVED AND DISCARDED BY PHYSICIAN SAME DAY. NO OTHER DEVICES FROM THE SAME BOX HAD THIS DEFECT. ON (B)(4) 2015 COMPLAINT HISTORY REVIEW FOUND NO PRIOR COMPLAINTS FOR THIS LOT. ON (B)(4) 2015 DEVICE HISTORY REVIEW FOUND KIT LOT 170407 CONTAINED CERVICAL BRUSH (A0040) LOTS BSCB41I AND BSCB42I. BOTH BRUSH LOTS PASSED TORQUE TEST QC SPECIFICATIONS. ON (B)(4) 2015 SUPPLIER NOTIFIED OF INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, QIAGEN RECEIVED A REPORT FROM (B)(6), (B)(4), WHERE A BRUSH HEAD DETACHED FROM THE SHAFT WHILE COLLECTING SAMPLE FROM PATIENT. THE PHYSICIAN REMOVED AND DISCARDED THE DEVICE BEFORE REPORTING THE INCIDENT TO QIAGEN. IN AN ABUNDANCE OF CAUTION, THIS INCIDENT IS BEING REPORTED NOW BECAUSE A SIMILAR COMPLAINT FOR THE SAME LOT WAS REPORTED (B)(4) THAT REQUIRED MEDICAL INTERVENTION FOR REMOVAL ALTHOUGH THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180317 DIGENE HC2 DNA COLLECTION DEVICE DIGENE HC2 DNA COLLECTION DEVICE HHT QIAGEN 170407

    Patients

    Seq Age Sex Outcome Treatment
    1