MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Catalog Number 11416755

Device Problem Low Test Results (2458)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested more information from the customer for evaluation.The customer has provided instrument files and investigation is underway.The cause of this event is unknown.

Event Description

The customer reported that their rp500 gave a discrepant calcium result compared to retesting of a new sample on a non-siemens instrument.

Manufacturer Narrative

Based on the data presented in this investigation, the ica++ sensor in the measurement cartridge was working as intended in and around the time of the reported discrepant results based on the sensor¿s slope and calibration stability, recovery of aqc and lack of any systemic or sensor related errors.The raw response curve generated by the ica++ sensor indicates the acceptable performance of the ica++ sensor.It should be noted, the results from ionized calcium and total calcium detection techniques should not be subjected to a direct comparison.Lastly, it should also be noted that proton pump inhibitors (ppi) such as ¿esomeprazole¿ and ¿omeprazole¿ which are the medications the patient of the escalated result was on can decrease the calcium levels in the blood.The definitive root cause for the discrepantly low result is unknown.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: tom myers ; 2 edgewater dr; norwood, MA 02062
• MDR Report Key: 16582373
• MDR Text Key: 312050195
• Report Number: 3002637618-2023-00014
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K192240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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