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	Abnormal Blood Gases (1034)
Date of Event	09/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.Calibration and qc reports have been provided for investigation.In addition, siemens has requested the paz file, trace log and type 2 cx logs to be provided for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant total hemoglobin results on the rp 500 and when compared to a non-siemens hematology analyzer.There was no report of harm due to this event.
Additional Manufacturer Narrative
Siemens has reviewed the files provided by the customer.The co-oximetry functionality on the rp500 appears to have been working as intended throughout the day of and including when the sample in question was measured.This is concluded based on the co-ox calibration stability, aqc expected recovery and lack of any relevant diagnostic errors or exception flags.It is known that for accurate thb measurements, whole blood specimens require the red blood cells to be uniformly distributed throughout the entire sample.This can be obtained only by thorough mixing of the blood sample across two planes performed immediately before analysis on the blood gas system as well as laboratory devices.It is unknown if the suspected high rp500 thb value occurred due to pre-analytic insufficient mixing.When comparing thb results between devices, factors that can impact observed bias include differences in matrix and measuring technology, sample mixing conditions, adequate draw volume, collection site, and cell clumping, and other pre-analytical conditions such as lipemia, icterus, and hemolysis.

• 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: 9120043
• Report Number: 3002637618-2019-00103
• Device Sequence Number: 2384051
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 09/07/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1