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

Model 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	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens reviewed the data logs provided by the customer.The co-oximetry functionality on the rl1265 appears to have been working as intended throughout the day of and including when the sample in question was measured.This is concluded based on the co-ox calibration stability, internal co-ox quality checks, aqc expected recovery and lack of any relevant diagnostic errors or exception flags.The reported thb values appear valid.It is known that for accurate thb measurements, whole blood specimens require the red blood cells to be uniformly distributed throughout the entire sample.This can be obtained only by thorough mixing of the blood sample across two planes performed immediately before each analysis.Service discussed the importance of pre-analytical concerns with the customer.The instrument is operational.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant total hemoglobin results on the rl 1265.There was no report of injury due to this event.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Common Device Name: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9729533
• Report Number: 3002637618-2020-00004
• Device Sequence Number: 11336615
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/19/2020

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 Model Number: 10321852
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1