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

Catalog Number 11416755

Device Problem Non Reproducible Results (4029)

Patient Problem Anemia (1706)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Siemens has requested the log files to be sent for investigation but to date, have not been received.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 a discrepant low total hemoglobin result on the rp 500e when compared to a non-siemens lab instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: the thb sensor was found, to be performing well within specifications without any evidence of a negative bias, during or around the time of the sample in question.There was insufficient data to perform any further investigation on the alleged discrepant result.Thb results are susceptible to sample mixing and handling.It would be the most likely, cause if the thb result is deemed as discrepant, but it could not be confirmed from the data reviewed.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11613641
• MDR Text Key: 243918598
• Report Number: 3002637618-2021-00021
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• 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: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1