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	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.The log files have been provided for investigation.The customer states that the measurement cartridge was replaced and they are operational.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant total hemoglobin results on the rp 500 when compared to a non-siemens hematology analyzer.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has reviewed the data provided by the customer.The thb sensor was found to be performing as intended.The aqc performance was well within specifications.There were no significant instrument errors reported at the time of the sample in question.No anomalies were found in the coox data.In the absence of a duplicate sample on the same or a like-for-like instrument, no further root cause analysis could be performed.Lower thb values are often linked to pre-analytical sampling steps, like hemolysis and sedimentation of blood cells.Thb measurement for blood samples not measured immediately after drawing is significantly affected by inadequate mixing.The reason for the discrepant result is inconclusive.

• 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: 8785516
• Report Number: 3002637618-2019-00079
• Device Sequence Number: 11273395
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 07/05/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1