BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1800

    MDR report key: 1889088 · Received October 28, 2010

    Report

    Report Number
    2432235-2010-00146
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CHECKED THE INSTRUMENT AND WAS UNABLE TO FIND A PROBLEM. THIS WAS CONSIDERED AN ISOLATED EVENT. THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CORRECTED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT PHOSPHOROUS RESULT WAS OBTAINED ON AN ADVIA 1800 FOR ONE PT. THE RESULT WAS REPORTED TO THE HEALTHCARE PROVIDER. THE PT SAMPLE WAS REPEATED ON THE SAME ADVIA 1800 SYSTEM AND THE CORRECTED RESULT WAS REPORTED. THERE WAS A REPORT THAT THE PT RECEIVED A PHOSPHATE (POLYFUSOR) INFUSION BECAUSE OF THE LOW RESULT. THE PT HAD A PRE-EXISTING LARGE BELL LYMPHOMA MEDICAL CONDITION AND WAS RECEIVING TREATMENT THAT MIGHT HAVE BEEN INTERFERING WITH THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1