MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 BLOOD GAS SYSTEM; RP 500

Catalog Number 10697306

Device Problem Non Reproducible Results (4029)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

The customer reported discrepant low total hemoglobin results for one patient run on the rp 500 when compared to repeat sample results in the normal range on the same rp 500.There was no report of injury due to this event.

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.The paz, r1 and cx files have been received for investigation.The customer stated the system is operational.The cause of the event is unknown.

Manufacturer Narrative

Siemens has completed the investigation: the measurement cartridge in question was found to be performing as intended.There were no system or sensor specific events recorded during and around the time of the reported sample.The raw response signals from the individual sensors were reviewed and found to be consistent with the generated results.The aqc performance for the sensor is well within specification for all levels.The root cause cannot be confirmed from the available information and instrument data.

• Brand Name: RAPIDPOINT 500 BLOOD GAS SYSTEM
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: felix akinrinola ; 511 benedict avenue; tarrytown, NY 10591 ; 6107052212
• MDR Report Key: 12835880
• MDR Text Key: 282568430
• Report Number: 3002637618-2021-00068
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• 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