MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500

Catalog Number 10697306

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.The customer has provided instrument log files and patient results for further investigation.The customer has declined further troubleshooting.Instrument is operational.The cause of this event is unknown.

Event Description

The customer received discordant thb results on several patients compared to retesting on a non siemens instrument with new samples.There was no report of injury due to this event.

Manufacturer Narrative

Based on the co-ox quality checks, performance with aqc, repeatability of sample concentrations as well as the lack of any calibration drift or diagnostic errors during the time period of the escalated events, the co-oximetry optical subsystem responsible for the measurement of thb was stable and functioning as expected.The reported values appear to be valid.The customer has been advised that if a systemic thb difference between the rp500 and the lab hematology instrument exist, a customized set of correlation coefficients could be established and implemented on the rp500 thb in order to better align to the pre-existing laboratory hgb assay.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10221124
• MDR Text Key: 197834690
• Report Number: 3002637618-2020-00029
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K122539
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1