BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 3831049 · Received May 23, 2014

    Report

    Report Number
    3005248192-2014-00004
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AND CONCLUSION OF ESCALATED COMPLAINT INVESTIGATION FOR THIS MDR: NO RETURNS WERE AVAILABLE TO EVALUATE. SITE INSPECTION WAS COMPLETED IN LIEU OF RETURNS. SITE INSPECTION REVEALED EIGHT REACTION VESSELS WITH A MISSING/DEFORMED COLLAR OUT OF 1000 REACTION VESSELS INSPECTED. RETAIN TESTING IS NOT APPLICABLE BECAUSE FILE SAMPLES OF THIS COMMODITY ARE NOT RETAINED. THE MOST LIKELY QUALITY ATTRIBUTE FOR A DEFORMED COLLAR IS THE SHORT SHOT SPECIFICATION. THIS SPECIFICATION ALLOWS FOUR SHORT SHOTS PERMITTED FOR EVERY 1000 INSPECTED. BECAUSE EIGHT REACTION VESSELS WITH A SHORT SHOT (MISSING/DEFORMED COLLAR) WERE FOUND OUT OF 1000 INSPECTED, THE PRODUCT IS NOT MEETING SPECIFICATIONS. BASED-UPON THE AVAILABLE INFORMATION, THE PRODUCT INVOLVED IN THIS INCIDENT IS NOT MEETING SPECIFICATIONS. THIS COMPLAINT IS THEREFORE CONFIRMED. A RISK ASSESSMENT IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE RISK ASSESSMENT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE 5 ML REACTION VESSELS (PART 04J71-20) LOT NUMBER USED BY THE CUSTOMER IN MDR 3005248192-2014-00004 WAS VENDOR LOT NUMBER 219807. AS A RESULT OF THE CONFIRMED COMPLAINT REPORTED IN MDR 3005248192-2014-00004, (B)(4) WAS OPENED AND IS IN PROGRESS. AS A RESULT OF THE RISK EVALUATION, ABBOTT MOLECULAR NOTIFIED THE FDA (B)(4) DISTRICT ON JUNE 19, 2014 THAT A 21 CFR 806 FIELD ACTION WAS BEING PREPARED FOR PART 04J71-20, VENDOR LOT 2198077 USED WITH THE ABBOTT M2000SP INSTRUMENT (LIST 09K14-02). THE ABBOTT MOLECULAR FIELD ACTION NUMBER IS FA-CAM-JUL2014-192. AN FDA RECALL NUMBER HAS NOT YET BEEN RECEIVED. ON JULY 3, 2014, THE FIELD CORRECTION RECALL / URGENT FIELD SAFETY NOTICE LETTER WAS ISSUED TO AFFECTED CUSTOMERS. THE CUSTOMER NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, THE POTENTIAL IMPACT, AND THE NECESSARY ACTIONS OF REMOVING ANY REMAINING PRODUCT (PART 04J71-20, VENDOR LOT 2198077) FROM USE AND TO CONTACT ABBOTT MOLECULAR TECHNICAL SUPPORT FOR PRODUCT REPLACEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4): SUPPLIER'S INVESTIGATION CONCLUSION OF ROOT CAUSE: THE ERROR REPORTED BY ABBOTT WAS NOT DUE TO AN INJECTION MOLDING PROCESS. THE ROOT CAUSE WAS ATTRIBUTED TO SUPPLIER REACTION VESSELS BEING MIXED WITH ABBOTT FLANGE REACTION VESSELS. THE MIXING OF THE TWO TYPES OF REACTION VESSELS IS MOST LIKELY DUE TO SUPPLIER MACHINE OPERATOR MISHANDLING OF FILLER REACTION VESSELS USED DURING THE PACKAGING PROCESS. MATERIAL CORRECTION: THERE WAS NO MATERIAL CORRECTION AT THE SUPPLIER, AND NO INVENTORY OF THIS LOT REMAINED AT THE SUPPLIER. THERE WAS NO MATERIAL CORRECTION AT ABBOTT, AND NO EXISTING INVENTORY OF THIS LOT REMAINED IN ABBOTT INVENTORY.

    Description of Event or Problem · 1

    THE ABBOTT M2000 REALTIME SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID AMPLIFICATION TESTING BY POLYMERASE CHAIN REACTION IN CLINICAL LABORATORIES. THE SYSTEM IS COMPOSED OF THE M2000RT AND THE M2000SP INSTRUMENTS. THE M2000SP IS INTENDED FOR AUTOMATED SAMPLE PREPARATION AND NUCLEIC ACID EXTRACTION PRIOR TO TESTING. ABBOTT M2000 SYSTEM CONSUMABLES INCLUDE THE 5ML REACTION VESSELS (PART (B)(4)). A CUSTOMER REPORTED TWO 5 ML REACTION VESSELS WERE MISSING A RIM AND FELL THROUGH THE 1ML SUBSYSTEM CARRIER WHEN SETTING UP A RUN. THERE WAS NO HARM REPORTED. THE IMPACT OF USING DEFECTIVE REATION VESSELS WITH MISSING RIMS IN M2000SP APPLICATIONS IS THAT THE REACTION VESSELS CANNOT BE HELD SECURELY IN THE 1 ML SUBSYSTEM CARRIER. THIS MAY CAUSE THE REACTION VESSELS TO DROP THROUGH THE CARRIER AND EXPOSE THE USER TO POTENTIALLY BIOHAZARDOUS AND/OR CHEMICAL MATERIALS DUE TO SPILLS. THIS MAY ALSO CAUSE REACTION VESSELS WITH MISSING RIMS TO BE SEATED INCORRECTLY IN THE CARRIER, POTENTIALLY CAUSING INCORRECT RESULTS (FALSE POSITIVE, FALSE NEGATIVE OR MISQUANTITATION) DUE TO INCORRECT SAMPLE OR REAGENT VOLUME TRANSFER OR DUE TO CROSS-CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307343 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1