BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST AIA-PROG SDS

    MDR report key: 1940938 · Received December 16, 2010

    Report

    Report Number
    3005529799-2010-00011
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 16, 2010
    Manufacturer
    TOSOH AIA INC.
    Product Code
    JLS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TOSOH NOTIFIED EACH OF THE FOLLOWING FOUR (4) CUSTOMERS WHO HAD RECEIVED THIS LOT, THE NOTIFICATION IS ATTACHED TO THIS FORM. TOSOH HAS PROVIDED REPLACEMENT PRODUCT AT NO CHARGE AND DESTROYED THE REMAINING STOCK OF LOT A952259. (B)(6). THIS PRODUCT IS USED FOR DIAGNOSTIC AND NO TREATMENT PURPOSES.

    Description of Event or Problem · 1

    ON (B)(6), TOSOH BIOSCIENCE WAS INFORMED BY (B)(4) WHO HAD ISSUED A RECALL OF SHORT TIME AUTOMATED IMMUNO ASSAY PROGESTERONE (ST AIA-PROG) SAMPLE DILUTING SOLUTION (SDS) LOT # A952259. THE PURPOSE FOR THIS RECALL IS THAT THIS LOT NUMBER OF SAMPLE DILUTING SOLUTION (SDS) WAS BOTTLED IN CLEAR GLASS BOTTLES, INSTEAD OF THE DESIGNATED BROWN GLASS BOTTLES. THIS VIOLATES THE DEVICE MASTER RECORD FOR THIS PRODUCT. NO DIRECT ILLNESS OR INJURY TO PATIENTS WILL RESULT BECAUSE THE PRODUCT IS AN IN VITRO DIAGNOSTIC REAGENT WHICH DOES NOT COME INTO CONTACT WITH THE PATIENT. THERE HAVE BEEN NO REPORTS OF ILLNESS OR INJURY IN THE USE OF THIS PRODUCT. IT HAS ALSO BEEN CONFIRMED THAT THERE IS NO EFFECT ON THE PERFORMANCE, EFFECTIVENESS AND SAFETY OF THE PRODUCT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST AIA-PROG SDS PROGESTERONE SAMPLE DILUTING SOLUTION JLS TOSOH AIA INC. A952259

    Patients

    Seq Age Sex Outcome Treatment
    1