MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 BLOOD GAS ANALYZER; RL 1265

Catalog Number	10321852
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens reviewed the data provided.The patient samples with the "d71 no sample detected at fd3" error messages, meaning the co-ox system did not detect the sample within the maximum amount of time allowed, also had d39 obstruction messages.A sample must be detected at fluid detector 3 (fd3) for the co-ox analysis to be performed.The sample not being pulled to the fd3 could be due to a number of reasons: a clot, too small of a sample, a fluid detector malfunction, or some other type of fluidic event.The presence of d39 obstruction errors supports the fact that clots were detected and prevented results from being able to be determined/reported.There is no indication that the system performed out of specification.Siemens states that the system is operational and is working correctly.
Event or Problem Description
The customer reported that the co-ox values for one patient could not be determined when run several times on the rl 1265 because the co-ox system did not detect the sample within the maximum amount of time allowed.In each instance a "d71 no sample detected at fd3" error message was received.The customer stated that this event caused a delay in measurement but the patient was not harmed.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Common Device Name: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8253523
• Report Number: 3002637618-2019-00008
• Device Sequence Number: 1946910
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K073537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1