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 08/02/2023

Event Type  malfunction  

Event Description

Customer reported that they received a discordant low result for thb compared to retesting of a different sample on a laboratory instrument.There is no report of injury due to this event.

Manufacturer Narrative

The customer has provided instrument log files.Investigation is underway.The cause of this event is unknown.

Manufacturer Narrative

Siemens reviewed the information provided by the customer.No interference was detected through the escalation date or while the sample in question was measured.A review of the data shows one d39 obstruction error occurred 5 minutes before sample analysis.The raw responses from both base analytes and coox subsystem passed internal quality checks for the patient sample.The sensors appear to be reporting results for the sample as presented.Thb measurement is dependent on the quality of the sample, and specifically the red blood cell concentration.Preanalytics such as the presence of a partial clot (indicated by the d39 error) may play a part in the discrepancy.For accurate measurement of thb in whole blood, thorough mixing and rotating of the red blood cells immediately before analysis is required.No product problem identified.

• 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, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17492230
• MDR Text Key: 320717323
• Report Number: 3002637618-2023-00058
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/03/2023

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: 08/03/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 10/03/2023
• 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: 49 YR
• Patient Sex: Female