MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; RP 500E

Model Number	11416751
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The optional handheld barcode scanner used for the rapidpoint 500e blood gas system allows scanning of operator id, patient id and accession number.Barcodes with check-digit have an additional digit at the end of the unique alpha/numeric string, providing an extra functionality that should reduce the frequency of erroneous scans.The scanner is not confirming the integrity of read barcode data using the check-digit.As a result of the issue, three scenarios can occur when rapidpoint 500e blood gas system is configured with code 39 check-digit selected, and the operator scans a code 39 barcode: the scanner might allow misinterpretation of barcode data which may lead to incorrect data entry for patient id or accession number because it matches an existing patient id or accession number values.This can cause the results of a particular sample to be mis-identified and potentially assigned to a different patient.The scanner might allow misinterpretation of barcode data which may lead to incorrect data entry for patient id or accession number that does not match any existing patient id or accession number values.This may lead to the sample being unmatched until the correct patient id or accession number is entered.The scanner might allow misinterpretation of barcode data which may lead to incorrect data entry for operator id or password.If this occurs, it may prevent the user from being immediately authenticated.This issue can be mitigated by rescanning the barcode.A customer notification will be published to provide the customer with a workaround to reconfigure the barcode scanner so that it will operate as intended.This issue was found internally.There are no reported customer complaints.
Event or Problem Description
Internal testing has determined that the rp500e external barcode scanner model ds4308 does not operate as intended when using code 39 with check digit enabled barcodes.There is a remote possibility of incorrect identification of patient results by the medical device when using this barcode scanner to scan patient ids with the indicated symbology.There have been no reports of injury due to this defect from customers.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Common Device Name: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10080026
• Report Number: 3002637618-2020-00023
• Device Sequence Number: 19561052
• Product Code: CHL
• UDI-Device Identifier: 00630414286143
• UDI-Public: 00630414286143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 11416751
• Device Catalogue Number: 11416751
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1