BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 5038919 · Received August 28, 2015

    Report

    Report Number
    1217157-2015-00124
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BARCODE READER S/N (B)(4) WAS RECEIVED FOR ESCALATION INVESTIGATION. THE BARCODE SUBMITTED IN THE COMPLAINT WAS OF VERY POOR QUALITY SHOWING MULTIPLE PRINT VOIDS. SIEMENS SOFTWARE ENGINEERING TESTED RETURNED BARCODE READERS; SEE BELOW RESULTS: CONNECTED THE EXTERNAL BARCODE SCANNER (MODEL#LS2208, SERIAL #(B)(4)) SENT FROM THE CUSTOMER TO A (B)(4) INSTRUMENT (B)(4). SCANNED ALL THE 16 ORIGINAL BARCODE LABELS (CAME WITH THE SCANNER) FROM THE DIFFERENT POSITIONS ON THE PATIENT DEMOGRAPHICS SCREEN. ALL THE BARCODE LABELS WERE READ SUCCESSFULLY. THE RESULT FROM EACH SCAN WAS CONSISTENT WITH THE ASCII STRING PRINTED BELOW THE BARCODE. REPEATED THE STEP 1 TO 2 FOR THE SECOND SCANNER ((MODEL#LS2208, SERIAL #(B)(4), ALSO SENT FROM THE CUSTOMER). ALL THE BARCODE LABELS WERE READ SUCCESSFULLY. THE RESULT FROM EACH SCAN WAS CONSISTENT WITH THE ASCII STRING PRINTED BELOW THE BARCODE. FROM THE TESTING RESULTS, I DIDN'T FIND ANY PROBLEM WITH THE SCANNERS. NO RESPONSE RECEIVED FROM CUSTOMER ON THEIR INTERNAL BARCODE GRADING SPECIFICATION. THE CUSTOMER COMPLAINT REGARDING BARCODE MISREAD ISSUE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    BASED UPON REVIEW OF THE BARCODE PICTURE SUBMITTED BY CUSTOMER, THE BAR CODE HAD MULTIPLE PRINT VOIDS THROUGHOUT THE BARCODE AND IT WAS POOR QUALITY PRINTED BARCODE LABEL. CUSTOMER INDICATED THAT THE ACTUAL BARCODE WAS ALREADY DISCARDED BY THE USER AS THIS WAS A BLOOD GAS SAMPLE. SIEMENS HAD PUBLISHED CUSTOMER BULLETIN 32716 REV A, TO EDUCATE CUSTOMER REGARDING BARCODE USAGE WITH SIEMENS' POINT OF CARE DEVICES" ON JUNE 2015. SIEMENS IS INVESTIGATING THE ISSUE. THE CAUSE FOR THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ONE OF THE DIGITS IN PATIENT ID BARCODE READ INCORRECT ON THE ANALYZER. CUSTOMER INDICATED THAT PATIENT ID READ AS (B)(6) INSTEAD OF (B)(6). CUSTOMER INDICATED THAT THEY WERE USING THE CODE 39 WITHOUT CHECK DIGITS. THERE WAS NO REPORT OF SERIOUS INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573191 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1