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

Model Number	10491449
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that handling errors cannot be ruled out.The customer has provided instrument files for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant total hemoglobin results on the rp500e when compared to repeat testing with the same sample on the same instrument.The customer does not know which is the correct result.There is no report of harm due to this event.
Additional Manufacturer Narrative
Siemens investigation has been completed.Based on the instrument log review, the root cause for the suspected discrepant thb result of 7.7 g/dl when compared to thb results of 6.1 g/dl and 6.2 g/dl performed from different arterial samples is unknown.There is no indication of a measurement cartridge issue and no thb sensor instability observed during sample analysis.There was no instrument malfunction, no contamination, nor any systematic or fluidic errors and the co-oximetry functionality appears to be working with no concerns indicating the rp500e sn: (b)(6) is performing as intended.It should be noted that a different arterial sample was measured each time on the rp500e sn: (b)(6) and the patient's health status could have changed from the first sample to the third sample.There was more than 1.5 hours that had elapsed from the first sample run at 00:32 to the second sample run at 02:48 and more than 3 hours elapsed from the second sample run at 02:48 to the third sample run at 06:11.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Common Device Name: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11417687
• Report Number: 3002637618-2021-00011
• Device Sequence Number: 11725788
• Product Code: CHL
• UDI-Device Identifier: 00630414589770
• UDI-Public: 00630414589770
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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 Model Number: 10491449
• Device Catalogue Number: 11416755
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1