BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN EMERALD

    MDR report key: 6447979 · Received March 30, 2017

    Report

    Report Number
    2919069-2017-00068
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    March 15, 2017
    Report Date
    May 19, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS AND A REVIEW OF LABELING. THE EMERALD EMISSIONS OF -6.7DB AND -5.7 DB FROM 30-1000MHZ ARE WELL BELOW THE LIMIT OF 47 DB(UV/M) OF (B)(4) STANDARD REQUIREMENT, THEREFORE, THE EMERALD WOULD NOT CAUSE ANY RADIO FREQUENCY INTERFERENCE (RFI) TO OTHER NEARBY ELECTRONICS SURROUNDING THE CELL-DYN EMERALD INSTRUMENT IF ALL OF THE OTHER ELECTRONIC DEVICES ARE IN COMPLIANCE WITH THE (B)(4) STANDARD REQUIREMENT. IN ADDITION, THE INSTRUMENT ELECTRICAL AND MECHANICAL COMPONENTS ARE ENCLOSED IN METAL OUTSIDE COVERS (SKIN) TO PREVENT INTERFERENCE FROM OR EMISSION OF ANY ELECTROMAGNETIC INTERFERENCE OR RADIOACTIVE INTERFERENCE AND ARE IN COMPLIANCE WITH EMC/SAFETY STANDARDS. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE AND CONTAINS THE FOLLOWING WARNINGS: DO NOT PLACE THE INSTRUMENT NEAR A CENTRIFUGE, X-RAY EQUIPMENT, VIDEO DISPLAY TERMINAL, COMPUTER, OR COPIER. CAUTION: DO NOT USE MOBILE TELEPHONES, WIRELESS TELEPHONES, MOBILE RADIOS, OR ANY OTHER RADIO FREQUENCY (RF) TRANSMITTING DEVICES IN THE SAME ROOM AS THE INSTRUMENT. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT WHO RECEIVED A DEFIBRILLATION SHOCK FROM HER PACEMAKER WHEN SHE ENTERED THE LAB. ONCE SHE EXCITED THE LAB HER PACEMAKER RETURNED TO NORMAL FUNCTION AND SHE DID NOT SEEK MEDICAL ASSISTANCE. THE PATIENT ((B)(6)) WAS APPROXIMATELY 8-10 FEET FROM EMERALD INSTRUMENT AT TIME OF ISSUE. OTHER INSTRUMENTS IN THE LAB AREA INCLUDE CLINITEK URINE ANALYZER, MINI-VES SED RATE ANALYZER, ARCHITECT ANALYZER AND GE HOME STYLE REFRIGERATOR. THE EMERALD OPERATIONS MANUAL INCLUDES THIS WARNING: CAUTION DO NOT USE MOBILE TELEPHONES, WIRELESS TELEPHONES, MOBILE RADIOS, OR ANY OTHER RADIO FREQUENCY (RF) TRANSMITTING DEVICES IN THE SAME ROOM AS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229983 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability