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

Catalog Number 10697306

Device Problem Low Test Results (2458)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the instrument log files for further investigation.Investigation has been completed.After reviewing the data logs from the rapidpoint instruments, the issue of discrepantly high na+ recovery was found to be limited to and caused by the reported patient samples.The rapidpoint instruments were found to be functioning as intended.The na+ results for the patient sample were flagged for being 'high' and the immediate sample or calibration following it were flagged for 'sodium sensor interferent detected' on all the rapidpoint instruments.

Event Description

Customer reported discrepant low thb (total hemoglobin) results for a patient sample that was analyzed on their rp500 instrument compared to the thb results when a new sample was tested on a non-siemens instrument.There was no report of injury due to this event.

Manufacturer Narrative

On (b)(6) 2023 siemens released an urgent medical device correction communication to customers.Siemens healthcare diagnostics inc.Has determined that two drugs, perhexiline maleate and atomoxetine hydrochloride, may interfere with sodium results that are reported on the rapidpoint 500 and rapidpoint 500e blood gas systems.The presence of perhexiline maleate and atomoxetine hydrochloride has the potential to cause erroneously elevated sodium results which may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia.Hyponatremia is associated with significant symptoms including nausea, malaise, headache, lethargy, obtundation and eventually seizures, coma, and respiratory arrest.Mitigations include the geographically restricted use of perhexiline maleate (which is mostly used in australia and new zealand), the short time-interval testing needs to occur after drug dosing for atomoxetine hydrochloride due to its short half-life, correlation of results with other electrolyte results such as chloride, historical sodium results, and the clinical history of the patient.Siemens healthcare diagnostics will be revising the rapidpoint 500 and rapidpoint 500e system operator's guide with information on the interfering substances.Once the revisions are completed, they will be available in siemens healthineers document library.

Event Description

Correction to intial report: this customer complaint was for discrepant sodium results, thb was not affected.The customer reported that their rp500 instrument gave a discrepant high sodium result on one patient compared to several sodium results generating from their laboratory analyzer from different samples.There is no report of injury due to this event.

Manufacturer Narrative

Information in sections b5 and b6 have been corrected.This customer complaint is for discrepant sodium only, hemoglobin is not affected.There is no indication that the drug interferences noted in mdr fu1 impact hemoglobin.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP500
• 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: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 15825887
• MDR Text Key: 307604740
• Report Number: 3002637618-2022-00063
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,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: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 09/26/2023; 09/26/2023
• Supplement Dates FDA Received: 10/16/2023; 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: CRR 3002637618-09-26-202
• Patient Sequence Number: 1