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

Catalog Number 11416755

Device Problem Low Test Results (2458)

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

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested instrument log files for further investigation.A siemens service engineer went onsite to perform system maintenance and change the measurement cartridge.The customer is operational.The cause of the event is unknown.

Event Description

The customer reported a discrepant low thb result compared to retesting of the same sample on a non-siemens lab instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation.Based on the co-ox subcomponent and sample quality checks, performance with aqc, lack of any co-ox related calibration drift or diagnostic errors during the time period of the escalated events, the co-oximetry optical subsystem responsible for the measurement of thb appeared stable and functioning as expected.The rp500e sn (b)(6) is performing as intended.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• 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 ; 62 flanders-bartly rd.; flanders, NJ 07836
• MDR Report Key: 13685272
• MDR Text Key: 289097356
• Report Number: 3002637618-2022-00016
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K192240
• 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: 04/07/2022

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: 11416755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 04/07/2022
• 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