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

Catalog Number 11416755

Device Problem Non Reproducible Results (4029)

Patient Problem Anemia (1706)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.The customer has provided the data files for investigation.The customer stated they replaced the measurement cartridge and reviewed sample handling with the operators and that they are operational.The cause of this event is unknown.

Event Description

The customer reported discrepant total hemoglobin results for one patient run on two rp 500e instruments.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: based on the co-ox quality checks, performance with aqc, lack of any co-ox related calibration drift or diagnostic errors during the time period of the escalated event, the co-oximetry optical subsystem responsible for the measurement of thb appeared stable and functioning as expected.The reported thb is based on measuring the blood cells as delivered to the co-ox slide cell.For an accurate measurement of thb, thorough mixing and multi-directional rotating of the red blood cells immediately before analysis is required.Insufficient mixing prior to the analysis can greatly alter the reported thb.A definitive root-cause for the observed discrepancy in thb results could not be identified.

• Brand Name: RADIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11628926
• MDR Text Key: 245385854
• Report Number: 3002637618-2021-00022
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K192240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11416755
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1