MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. 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 09/21/2023

Event Type  malfunction  

Event Description

Customer alleges multiple discrepant low k+ results compared to retesting of a new serum sample on a non-siemens lab instrument.There is no report of injury due to this event.

Manufacturer Narrative

The customer has provided instrument files for further investigation.Investigation is underway.The customer replaced their measurement cartridge and are currently operational.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation.The customer provided instrument log files, automatic quality control (aqc) files and sensor files.A review of this data indicates that the potassium sensor was performing as intended at time of analysis on the escalated samples.The instrument did not generate any error messages related to potassium sensor performance.It should be noted that pre-analytics such as differences in matrices (serum vs whole blood), collection practices, sample inhomogeneity, and time differences between comparative measurements may play a part of the observed difference between the results.The measurement cartridge was replaced, and the customer is operational.Although a definitive root cause could not be determined, there is no indication that the instrument is not operating as intended.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17868958
• MDR Text Key: 325843230
• Report Number: 3002637618-2023-00080
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/07/2023

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: 09/25/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male