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

Catalog Number 10697306

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The customer reported that repeat testing was performed on another rp 500 to confirm correct results and a corrected report was issued.The cause for the discrepant results is unknown.

Event Description

The customer reported discrepant po2 results.There was no report of injury due to this event.

Manufacturer Narrative

The measurement cartridge was not returned to siemens for evaluation.The data files for instrument sn (b)(4) were provided and reviewed by siemens.The data indicates that a d39 error (obstruction) occurred at the time of the testing of the sample in question which is likely to have caused the lower po2 value.As stated in the rp500 operators guide: when a d39 error occurs, the system detects a problem, such as an obstruction or a sample not detected, and prompts the operator to replace the sample port.If the system is unable to clear the obstruction, it prompts the operator to replace the cartridge.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6107398
• MDR Text Key: 60558157
• Report Number: 3002637618-2016-00151
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR