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 08/07/2023

Event Type  malfunction  

Event Description

The customer reported a discrepant low neonatal bilirubin result on their rp500e instrument compared to retesting of a new sample on a non siemens lab instrument.

Manufacturer Narrative

Siemens has requested instrument log files for further analysis.The cause of this event is unknown.

Event Description

The customer has clarified that there was a typo in the original escalation.The 23.0mg/dl result was received by the rp500e and 18.2mg/dl by the lab instrument.Customer is alleging a discrepant high nbili result.

Manufacturer Narrative

Based on the customer clarification, this event no longer meets the criteria of a potential for serious injury."a falsely elevated neonatal bilirubin value by =+0.4 mg/dl or +20% (whichever difference is greater) may lead to unnecessary intervention for hyperbilirubinemia.However, results are correlated with clinical presentation and previous results.Potential for serious injury: no." siemens reviewed the available system logs, there were no systemic or sensor related events recorded during or around the time of the escalated sample.The measurement cartridge in use at the time of the event, including the co-oximetry subsystem appears to be performing as intended.Aqc for all three levels recovered within expected range including the date of the event.The observed n-bili discrepancy appears to be sample specific.The rp500e instrument is performing as intended and currently operational.Section b has been updated to reflect the clarification received from the customer.

• 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: 17560088
• MDR Text Key: 321384555
• Report Number: 3002637618-2023-00066
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/19/2023

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: 08/09/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 09/19/2023
• 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: 1 YR