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

Catalog Number 10697306

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

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.The data files have been requested for investigation.The cause of this event is unknown.

Event Description

The customer reported discrepant total hemoglobin results when tested on the rp 500 and a non-siemens lab analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens evaluated the data provided by the customer.Review of the data files do not indicate any performance issues with thb around the time the discordant sample was reported.The data indicates that different types of methodologies and sample matrices of the laboratory devices versus point of care devices may have influenced the discrepancies observed.Review of the sample in question indicates there were no flagged results, the system was not in retrocal and no reported thb calibration drift errors.The aqc results were in the expected ranges.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; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7519869
• MDR Text Key: 108863931
• Report Number: 3002637618-2018-00059
• Device Sequence Number: 0
• Product Code: GKR
• Combination Product (y/n): N
• PMA/PMN Number: K113216
• 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: 07/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR