BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON SIGNATURE+

    MDR report key: 881677 · Received July 15, 2007

    Report

    Report Number
    MW5003045
    Event Type
    Other
    Date Received
    July 15, 2007
    Report Date
    July 15, 2007
    Manufacturer
    ITC
    Product Code
    JPA
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER OF THE HEMOCHRON JR SIGNATURE+ ACTIVATED CLOTTING TIME -ACT- TEST CUVETTES, FACILITY CHANGED THEIR PACKAGE INSERT AND PRODUCT USE RECOMMENDATIONS AND DID NOT NOTIFY PRODUCT USERS OF THE CHANGES. PREVIOUSLY, EXTERNAL LIQUID QUALITY CONTROL WAS RECOMMENDED TO BE PERFORMED WITH EACH NEW LOT OR SHIPMENT OF TEST CUVETTES. FACILITY CHANGED THE RECOMMENDATION TO ONCE EACH NEW LOT OR SHIPMENT AND EVERY 30 DAYS THEREAFTER. WITHOUT THE NOTIFICATION, LABS ARE NOT IN COMPLIANCE WITH THE ACCREDITING AGENCIES STANDARDS-CAP AND JCAHO-. PREVIOUSLY, TEST CUVETTES PREVIOUSLY COULD BE STORED UNOPENED AT ROOM TEMPERATURE FOR 14 DAYS. THE NEW PACKAGE INSERT STATES THAT UNOPENED TEST CUVETTES CAN BE STORED AT ROOM TEMPERATURE FOR 12 WEEKS. WHEN I CALLED MY REP, HE STATED THAT THIS WAS AN INTENTIONAL DECISION BY ITC BASED ON FINANCES. IF THEY HAD NOTIFIED USERS OF THE CHANGES, CUSTOMERS WOULD HAVE REQUESTED THAT THE PRODUCT BE REPLACED BY THE NEWER LOTS, WHICH WOULD HAVE BEEN A FINANCIAL BURDEN ON THE FACILITY. I AM REPORTING THIS EVENT BECAUSE USERS OF ITCS PRODUCTS NEED TO BE AWARE OF CHANGES IN MFR RECOMMENDATIONS IN ORDER TO CONTINUE TO PROVIDE QUALITY PT CARE AND TO BE IN COMPLIANCE WITH ACCREDITING AGENCIES. DATES OF USE: 2005 - 2007. DIAGNOSIS OR REASON FOR USE: PERFORMING ACT TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE+ NONE JPA ITC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other