MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500

Catalog Number	10492730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which matched the patients appearance and condition and a corrected report was issued.Siemens has requested the instrument data logs to be provided for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant ph results between capillary and arterial samples run on two rp 500s.The capillary samples from (b)(6) 2018 did not match the baby's appearance or condition.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has requested additional information from the customer.The data files for the other rp 500 s/n (b)(4) on which comparative analysis was performed are required for the investigation.These files have been requested three times and have not been received.The investigation is being closed due to insufficient information needed to complete the investigation.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7357992
• Report Number: 3002637618-2018-00034
• Device Sequence Number: 16186329
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA