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

Catalog Number	10492730
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results.The cx, r1and paz files have been requested for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported a discrepant total hemoglobin run on the rp 500 when compared to a non-siemens lab analyzer and another rp 500.There is no report of injury due to this event.
Additional Manufacturer Narrative
Mfr site: updated contact office - name/address.Siemens reviewed the data files.The thb values for the patient samples in question appear valid.There is no indication of any performance issues with the thb.There is no data that suggestions that the co-ox module was mal-functioning.No interfering substances were identified, and no co-ox diagnostic errors were flagged.The thb values may have differed due to the separate patient draws or sampling handling.If the samples are not well mixed at the time of the test, the blood cells will settle and give a different result when compared to a well-mixed sample.Known differences within methodologies and sample matrices between the laboratory devices and the point of care systems may have influenced the discrepancies observed.The cause of this event is unknown.

• 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: 8545046
• Report Number: 3002637618-2019-00050
• Device Sequence Number: 400098
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR