MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS SYSTEM; RP500

Model Number	10491449
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a discrepant low thb (total hemoglobin) result generated on the rp500 compared to the thb result of a different sample on a non-siemens instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
An investigation is currently underway which includes a review of the instrument log files the customer provided.Customer is operational.The cause of this event is unknown.
Additional Manufacturer Narrative
Siemens has completed the investigation.The definitive root-cause for the low thb could not be determined.Based on the investigation this rp500 system appeared stable and functioning as expected.Data did not suggest anything unusual about the co-ox behavior of this patient or that hemodialysis impacted the thb result.The reported thb results appear valid.For an accurate measurement of thb, thorough mixing and multi-directional rotating of the red blood cells immediately before analysis is required.This is particularly important for blood samples of lower hematocrit (red blood cells) as the cells more quickly settle out, falling out of homogeneity.Pre-analytical sample condition(s) is most likely a primary contributor to the observed discordant thb values.Cause of this event is unknown.

• Brand Name: RAPIDPOINT 500 BLOOD GAS SYSTEM
• Common Device Name: RP500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; northern road; chilton industrial estates; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 511 benedict ave; tarrytown, NY 10591
• MDR Report Key: 15258013
• Report Number: 3002637618-2022-00054
• Device Sequence Number: 6614084
• Product Code: CHL
• UDI-Device Identifier: 00630414589770
• UDI-Public: 00630414589770
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown