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

Model Number 10491449

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 298210537
• Report Number: 3002637618-2022-00054
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414589770
• UDI-Public: 00630414589770
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 10491449
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1