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

Catalog Number 10697306

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested instrument log files for further investigation.Files from customer are yet to be received.The cause of this event is unknown.

Event Description

The customer reported a discrepant low sodium result on their rp500 instrument compared to retesting of a new sample on a non-siemens lab instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation.The log files were investigated and it was found that device was working as intended and system is currently operational.The discrepancies may have been due to sampling differences and differences in sample type.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500 BLOOD GAS SYSTEM
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 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: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 3392067452
• MDR Report Key: 14251305
• MDR Text Key: 290469593
• Report Number: 3002637618-2022-00030
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/08/2022
• 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