BEUDAMED
    FDA Adverse Event Summary report: N

    1823260-2010-06030

    MDR report key: 1863484 · Received October 11, 2010

    Report

    Report Number
    1823260-2010-06030
    Date Received
    October 11, 2010
    Report Date
    November 4, 2010
    Product Code
    JJE
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR 1 PATIENT ON THE COBAS ANALYTICAL E MODULE FOR THE INTACT HUMAN CHORIONIC GONADOTROPIN + BETA- SUBUNIT (HCG+BETA) ASSAY. THE CUSTOMER STATED THAT THEY OBTAINED AN INITIAL HCG+BETA RESULT OF > 10,000 WITH A DATA FLAG, WHICH WAS NOT REPORTED OUTSIDE THE LABORATORY. REPEAT TESTING YIELDED A RESULT OF 2.00 WITH A DATA FLAG, WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE ASSAY WAS REPEATED AGAIN WITH A VALUE OF 40,011, WHICH WAS ALSO REPORTED OUTSIDE THE LABORATORY AS A CORRECTED REPORT. THE UNITS OF MEASURE WERE NOT PROVIDED. THE PATIENT WAS REFERRED TO A GP FOR FOLLOW-UP. THERE WAS NO ALLEGATION OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE LOT NUMBER OF HGC+BETA REAGENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED AN AIR IN LINE ALARM. THIS CONDITION MAY BE A FALSE AIR IN ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JJE

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR