BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERKINELMER 226 SAMPLE COLLECTION DEVICE

    MDR report key: 3525401 · Received December 11, 2013

    Report

    Report Number
    3007145015-2013-00001
    Event Type
    Death
    Date Received
    December 11, 2013
    Date of Event
    October 28, 2013
    Report Date
    December 11, 2013
    Manufacturer
    PERKINELMER HEALTH SCIENCES, INC.
    Product Code
    JKA
    PMA / PMN Number
    K121864
    Removal / Correction Number
    RECALL Z-0030-2014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL Z-0030-2014 INVOLVED A SINGLE CUSTOMER ((B)(6) DEPARTMENT OF HEALTH) RECEIVING (B)(4) POTENTIALLY AFFECTED DEVICES. DURING THE RECALL IT WAS DETERMINED THAT (B)(4) DEVICES HAD BEEN USED TO COLLECT BLOOD FOR NEWBORN SCREENING AND THE TESTING COMPLETED PRIOR TO THE RECALL MITIGATION ACTIVITIES PROVIDING NON-AFFECTED DEVICES FOR SAMPLE COLLECTION. THROUGH DIALOGUE WITH FDA, PERKINELMER AND THE (B)(6) DEPARTMENT OF HEALTH, THE DECISION WAS MADE TO RECOMMEND THE 132 NEWBORNS RETURN TO HAVE A SECOND BLOOD SAMPLE TAKEN AND NEW TESTING PERFORMED. THE PROCESS OF RECALLING NEWBORNS FOR RECOLLECTION IS IN PROCESS.

    Description of Event or Problem · 1

    IN CONJUNCTION WITH MEDICAL DEVICE RECALL Z-0030-2014 FOR THE PERKINELMER 226 SAMPLE COLLECTION DEVICE, 132 NEONATAL PTS WHOSE BLOOD WAS COLLECTED WITH POTENTIALLY AFFECTED DEVICES WERE REQUESTED (VIA PHYSICIAN NOTIFICATION) TO RETURN FOR THE COLLECTION OF A SECOND BLOOD SAMPLE FOR REPEAT TESTING. WHILE IN THE PROCESS OF MONITORING THE NUMBER OF PTS RESPONDING, THE OHIO DEPARTMENT OF HEALTH NOTIFIED A PERKINELMER SALES REP THAT 1 OF THE 132 NEWBORN PTS WAS DECEASED. (B)(6) DEPT OF HEALTH WAS CONTACTED FOR ADDITIONAL INFORMATION TO FACILITATE THE MDR REPORTING, AND PROVIDED THE FOLLOWING; LABORATORY RECORD (PT ID, NAME, DOB, GENDER, PARENT'S NAME, ADDRESS, PHONE, BIRTH HOSPITAL), BIRTH WEIGHT (B)(6), DATE OF DEATH ((B)(6) 2013), INTERPRETATION OF NEWBORN SCREENING PANEL (SCREEN WAS REPORTED AS LOW RISK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646828 PERKINELMER 226 SAMPLE COLLECTION DEVICE BLOOD SPECIMEN COLLECTION DEVICE JKA PERKINELMER HEALTH SCIENCES, INC. GR226313119 OH HEA 2518

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death