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 02/23/2021

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 additional.Cx files for investigation.The customer stated that all calibrations had passed and the qc was within range for thb prior to the sample being run on the rp500e.The cause of this event is unknown.

Event Description

The customer reported discrepant low total hemoglobin results on one patient on the rp 500e when compared to a non-siemens lab instrument.The customer stated that the need for a second blood draw may have caused additional stress to the patient.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: a review of the instrument log shows 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.The likely cause of the low thb result was that customer stated that a different capillary sample was used for each measurement and that the specimen was not properly mixed prior to analysis on the rp 500e.

• 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: 11464135
• MDR Text Key: 240624388
• Report Number: 3002637618-2021-00014
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 DA