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

Catalog Number 10697306

Device Problem Low Test Results (2458)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

The customer reported that their rp500 instrument gave several discrepant low total hemoglobin (thb) results compared to retesting on the same instrument on the same day for seven patients.It is unknown if new samples were drawn.There is no report of injury due to this event.

Manufacturer Narrative

The customer has provided instrument log files for further investigation.The investigation is underway.Customer is operational.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation of the instrument log files.A conclusive root-cause for the low thb is unknown.The review of the optical subcomponent quality diagnostics suggests unusual optical scattering, possibly caused by an occlusion.This could not be verified, as the measurement cartridge was not available.This sequence of events is uncommon.And appears to have been resolved upon cartridge replacement.The rp500 system is reported as active.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 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 ; 6107052212
• MDR Report Key: 14491562
• MDR Text Key: 292604444
• Report Number: 3002637618-2022-00036
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 05/31/2022
• 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