BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEP 8 (D8Z2) SPECTRUMGREEN PROBE

    MDR report key: 3019748 · Received March 25, 2013

    Report

    Report Number
    3005248192-2013-00008
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MVU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT MOLECULAR INVESTIGATION CONFIRMED THIS ISSUE AS A PRODUCT MALFUNCTION. (B)(4) CAPA WAS OPENED AS A RESULT OF THIS MALFUNCTION ISSUE AND IS IN PROGRESS. AN MDR FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE 556-CAPA INVESTIGATION REACHES A CONCLUSION. ABBOTT MOLECULAR IS PREPARING AN 806 FIELD ACTION TO NOTIFY AFFECTED CUSTOMERS. PREVIOUSLY REPORTED MDRS RELATED TO THIS SAME MALFUNCTION ISSUE: 3005248192-2013-00005; 3005248192-2013-00006; 3005248192-2013-00007.

    Description of Event or Problem · 1

    BACKGROUND: THE CEP 8 SPECTRUMGREEN (SG) ASR PROBE KIT, 20UL (LIST 06J37-018) IS AN ANALYTE SPECIFIC REAGENT (ASR) CONTAINING A SINGLE VIAL OF CEP 8 SPECTRUM GREEN PROBE AND A CERTIFICATE OF ANALYSIS (COA). CHROMOSOME ENUMERATION PROBES (CEP) ARE CHROMOSOME-SPECIFIC FISH PROBES THAT HYBRIDIZE TO HIGHLY REPETITIVE HUMAN SATELLITE DNA SEQUENCES, USUALLY LOCATED NEAR CENTROMERES. CEP SIGNALS ENABLE THE IDENTIFICATION AND ENUMERATION OF HUMAN CHROMOSOMES IN INTERPHASE AND METAPHASE CELLS FROM FRESH AND ARCHIVED SAMPLES. THE LABEL FOR CEP 8 SG ASR PROBE KIT INDICATES IT IS AN ANALYTE SPECIFIC REAGENT, AND ANALYTICAL AND PERFORMANCE CHARACTERISTICS ARE NOT ESTABLISHED. ISSUE: A CUSTOMER RECEIVED FIVE KITS OF CEP 8 SG ASR PROBE (LIST 06J37-018, LOT 440023), CONTAINING VYSIS CEP 4 (ALPHA SATELLITE) SG PROBE, 20UL, (PART 32-112004, LOT 438814) INSTEAD OF THE EXPECTED CEP 8 PROBE. THE CUSTOMER DID NOT USE THE KITS CONTAINING THE INCORRECT COMPONENT. ABBOTT MOLECULAR SENT REPLACEMENT KITS TO THE CUSTOMER. THE CUSTOMER RETURNED THE FIVE KITS CONTAINING INCORRECT COMPONENTS TO ABBOTT MOLECULAR. IMPACT: PRODUCT FUNCTIONALITY IS IMPACTED BECAUSE USE OF CEP 4 (SG) WOULD NOT ACCURATELY ENUMERATE CHROMOSOME 8. THE CEP 8 SG PROBE AND THE CEP 4 SG PROBE BOTH PRODUCE GREEN SIGNALS NEAR THE CENTROMERE OF THEIR RESPECTIVE CHROMOSOMES. THE PRESENCE OF SPECTRUM GREEN SIGNALS NEAR THE CENTROMERE MAY LEAD THE TECHNICIAN TO CONCLUDE THE TEST WAS PERFORMED CORRECTLY. IF CEP 8 POSITIVE CONTROLS ARE NOT RUN WITH PATIENT SAMPLES, THEN THE POTENTIAL EXISTS TO GENERATE INCORRECT RESULTS. NOTE: THE CEP 4 PROBE VIALS WERE CORRECTLY LABELED TO IDENTIFY THE ACTUAL CONTENTS OF CEP 4 PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122791 CEP 8 (D8Z2) SPECTRUMGREEN PROBE ANALYTE SPECIFIC REAGENTS MVU ABBOTT MOLECULAR, INC. 440023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other