MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS SYSTEM; RP500

Catalog Number 10697306

Device Problem Low Test Results (2458)

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

Event Date 07/26/2022

Event Type  malfunction  

Event Description

Customer reported their rp500 analyzer generated a discrepant low k+ (sodium) result when compared to the k+ result of a different sample performed on a lab instrument.No patient injury reported.

Manufacturer Narrative

An investigation is currently underway which includes a review of the instrument log files the customer provided.Customer is operational.The cause of this event is unknown.

Manufacturer Narrative

Siemens has concluded its investigation.A review of the rp500 sodium and potassium sensors' reagent millivolt, sensor slope and raw response curves as well as calibration history for this system indicate that the sodium and potassium sensor were functioning as expected.The observed differences in the sodium and potassium values between the rp500 and the chemistry lab measurement may be affected by differences in methodologies and sample matrixes between the point of care device and the chemistry system.The literature suggests that for sodium, serum samples typically run higher than whole blood samples.The different methodologies (direct vs indirect) will play as a factor since indirect is affected by the amount of protein and lipids dissolved in the sample.A definitive root-cause for the discrepant values could not be determined.

• Brand Name: RAPIDPOINT 500 BLOOD GAS SYSTEM
• Type of Device: RP500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; 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: tom myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 15245308
• MDR Text Key: 299282434
• Report Number: 3002637618-2022-00055
• 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: 09/12/2022

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 Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/12/2022
• 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