BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA BIOSYSTEMS

    MDR report key: 5141826 · Received October 7, 2015

    Report

    Report Number
    3004859032-2015-00001
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    September 9, 2015
    Report Date
    October 5, 2015
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Product Code
    MVU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN SERIAL SECTIONS OF (B)(6) SKIN SAMPLE (TISSUE ID (B)(6)) WERE STAINED USING BOTH THE CUSTOMER RETURNED AND RETAINED UNITS OF THE BATCH (PB0780, 30241), NO ISSUES WITH (B)(6) STAINING WERE OBSERVED. BOTH PROBES YIELDED STAINING OF AN APPROPRIATE AND ACCEPTABLE INTENSITY AND PATTERN. NO NON-SPECIFIC OR BACKGROUND STAINING WAS OBSERVED. THE DNA (B)(6) AND DNA (B)(6) CONTROLS ALSO STAINED AS EXPECTED, PROVIDING FURTHER CONFIDENCE OF THE PRESENCE OF (B)(6) CELLS. WHILST THE CUSTOMER USES (B)(6) CONTROL TISSUE, THEY DO NOT USE DNA CONTROLS. THIS WOULD HELP PROVIDE MORE INFORMATION REGARDING THE STAINING PATTERN OF ANY TISSUE USED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    LEICA (B)(4) RECEIVED A COMPLAINT ON (B)(6) 2015 REGARDING A FALSE POSITIVE RESULT OBTAINED WITH A HPV PROBE (PRODUCT CODE PB0780). THE SAMPLES AND ALSO THE NEGATIVE CONTROLS ALL DEMONSTRATED POSITIVE STAINING. THE CUSTOMER RE RAN THE TESTS WITH 2 OTHER VIALS OF PRODUCT (THEREFORE USING 3 SEPARATE VIALS IN TOTAL) AND OBTAINED THE SAME RESULTS. ALL THREE VIALS USED IN TESTING WERE FROM LOT 30241. ON (B)(6) 2015, LEICA (B)(4) RECEIVED INFO THAT TISSUE FROM 1 PT DEMONSTRATED FALSE POSITIVE STAINING. THE PT TISSUE HAS BEEN TESTED 3 TIMES IN TOTAL. THIS TOOK 3 WEEKS. THE DIAGNOSIS WAS THEREFORE DELAYED FOR 3 WEEKS AND WAS FINALLY REPORTED AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664413 LEICA BIOSYSTEMS HPV PROBE (SUBTYPES 6, 11) MVU LEICA BIOSYSTEMS NEWCASTLE LTD 30241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other