BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 405

    MDR report key: 4724493 · Received April 23, 2015

    Report

    Report Number
    1217157-2015-00050
    Date Received
    April 23, 2015
    Date of Event
    November 9, 2014
    Report Date
    March 29, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF BOTH THE RP405 LOG FILES AND RAPIDCOMM SHOW THE PATIENT ID ENTERED IN THE RP405 SYSTEM IS THE SAME ONE THAT WAS TRANSMITTED TO RAPIDCOMM. THIS SHOWS THAT THE PATIENT ID ENTERED BY THE CUSTOMER IS THE PATIENT ID TRANSMITTED. SAMPLE ORDER FROM RAPID COMM (B)(6) 2014 04:36 JXXXX BABY GIRL 1 ((B)(6)) (B)(6) 2014 04:39 HXXXX BABY BOY ((B)(6)) (B)(6) 2014 04:49 HXXXX BABY BOY ((B)(6)) PATIENTS JXXXXX HAS BABY 1 AND BABY 2 (TWINS); ON (B)(6) 2014 JXXXXX BABY 1 ((B)(6)) WAS TESTED @ 4:36 AM BUT NO JXXXXX BABY 2 (PATIENT ID NOT PROVIDED). IT WAS NOT UNTIL (B)(6) 4:52 AM THAT JXXXXX BABY 2 HAD A SAMPLE RUN (NO DATA PROVIDED). THE 3RD SAMPLE LISTED ON (B)(6) @ 4:49 IS THE SAMPLE THEY INITIALLY BELIEVED SHOULD HAVE BEEN JXXXX BABY 2 COMING OVER BUT RAPIDCOMM SAYS IT IS PATIENT HXXXXX ((B)(6)) AND THE SYSTEM LOG (PAZ) FILE SHOWS PATIENT HXXXXX ((B)(6)) FOR BOTH SAMPLES AS WELL. BABY 1 JXXXX (1428400354) AND BABY HXXXXX ((B)(6)) WERE TESTED AT ABOUT THE SAME TIME ON (B)(6) 2014 ~ 4:39; REVIEW OF SAMPLE LOGS SHOWED RESULTS FOR BABY HXXXXX ((B)(6)) HAD A BIG CHANGE IN SAMPLE RESULTS(PH AND PCO2) IN <12 MINUTES. PH/PCO2 TYPICALLY DO NOT CHANGE THIS AMOUNT DURING A 12 MINUTE SPAN. THIS LEADS TO FURTHER EVIDENCE THERE WAS A PREANALYTICAL SAMPLE LABELING OR SCANNING ISSUE BY THE CUSTOMER. SIEMENS CUSTOMER COMPLAINT CENTER TEAM WHO WORKED WITH THE CUSTOMER TO REVIEW THE RAPIDCOMM LOGS INDICATED THAT THE CUSTOMER DID NOT WANT TO INVESTIGATE ANY FURTHER AND WILL BE LOOKING AT THEIR INTERNAL PRACTICES WITH BAR CODE LABELS. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY SCANNED A PATIENT ID ON THE INSTRUMENT AND WHEN IT CROSSED OVER TO RAPIDCOMM IT WAS A DIFFERENT PATIENT ID. CUSTOMER INDICATED THAT THEY CAUGHT THE INCORRECT PATIENT ID AND CORRECTED THE ISSUE AND THEY HAVE NOT HAD ANY OTHER SIMILAR ISSUE EVER SINCE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269758 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1