BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDLAB 1265

    MDR report key: 4170080 · Received October 14, 2014

    Report

    Report Number
    1217157-2014-00157
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE WERE NO ADVERSE PATIENT OUTCOMES DUE TO CHANGES IN TREATMENT OR ACTIONS MADE BASED ON THE INCORRECT GLUCOSE OR LACTATE RESULTS. CUSTOMER ALSO MENTIONED THAT ONE OF THE PATIENTS DIED AT A LATER TIME, BUT THIS HAPPENED IN A DIFFERENT WARD AND THEY DIDN'T THINK IT WAS RELATED TO THE INCORRECT GLUCOSE RESULT. BASED ON FURTHER COMMUNICATION WITH CUSTOMER, THEY CONFIRMED THAT THE DEATH OF THE PATIENT WAS NOT RELATED TO THE RESULTS REPORTED WHEN THE SENSORS WERE INSTALLED IN THE INCORRECT POSITIONS BY THE CUSTOMER. THERE WAS NO REPORT OF INJURY TO ANY PATIENT DUE TO THIS EVENT. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Additional Manufacturer Narrative · 1

    THE RAPIDLAB 1200 OPERATOR'S GUIDE INSTRUCTS THE USER TO RUN TWO LEVELS OF QUALITY CONTROL AFTER COMPLETING SAMPLE PATHWAY DEPROTEINIZING MAINTENANCE. IF THE QUALITY CONTROL WAS RUN, THE CONTROL WOULD HAVE FAILED AND DISABLED BOTH THE GLUCOSE AND LACTATE PARAMETERS AND OPERATOR ATTENTION WOULD HAVE BEEN NEEDED PRIOR TO RUNNING SAMPLES. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR. THE INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT GLUCOSE AND LACTATE SENSORS SWAPPED ON THE INSTRUMENT AND SYSTEM CALIBRATED. CUSTOMER INDICATED THAT 16 PATIENT SAMPLES WERE RUN DURING THAT TIME. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649470 RAPIDLAB 1265 RL1265 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1