BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR SIGNATURE SYSTEM

    MDR report key: 2253539 · Received September 12, 2011

    Report

    Report Number
    2248721-2011-00114
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    May 11, 2011
    Report Date
    September 6, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K940401
    Removal / Correction Number
    Z-2953-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # M0JPT097. ADD'L EXPIRATION DATE: 03/2012. THIS MDR SUBMITTED (B)(6) 2011 REFERENCES ITC COMPLAINT # 101717 (CUVETTE LOT# G0JPT075, M0JPT097). METHOD: NO PRODUCT RETURNED. RESULT: MFR NOTIFIED FDA ON OR ABOUT (B)(6) 2011 OF HEMOCHRON JR PT J201 VOLUNTARY RECALL. CONCLUSION: CUVETTE LOTS RECALLED (Z-2953-2011) DUE TO HIGHER THAN SPECIFIED BIAS. CORRECTIVE ACTION (B)(4) IMPLEMENTED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    THIS IS A MFR'S F/U REPORT TO THE USER FACILITY REPORT REFERENCED ABOVE, REC'D BY ITC ON (B)(6) 2011. FOLLOWING NOTIFICATION OF J201 RECALL, CUSTOMER NOTIFIED FDA TO REPORT THAT PT MAY HAVE BEEN ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR SIGNATURE SYSTEM JPA INTERNATIONAL TECHNIDYNE CORPORATION G0JPT075

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other