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

Catalog Number	10321852
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested instrument log files for further investigation.Investigation will commence once requested data has been received.The cause of this event is unknown.
Event or Problem Description
The customer reported that they received a discrepant high total hemoglobin (thb) result compared to retesting of the same sample on another rl1265 instrument and a different sample on their laboratory instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
Investigation has been completed.The co-oximetry optical subsystem responsible for the measurement of thb appeared stable with constant temperature and in control during the sample measurements.No co-ox interference was detected through the escalation date and while the sample in-question was measured.Review of provided data declares thb aqcs recovered well within expected range prior and after the escalated sample measurement as well as throughout the entire reported day.Optical thb measurement is dependent on the quality of the sample, and specifically the red blood cell concentration as presented in the slide cell.Pre-analytics such as differences in matrices, collection practices, light exposure, insufficient mixing, sample inhomogeneity, and time differences between comparative measurements may have attributed to the observed difference between the results of rl1265 sn 18875 and two comparative systems.For an accurate measurement of thb in whole blood, it is known that thorough mixing and rotating of the red blood cells immediately before analysis is required.The cause of this event is unknown.The instrument is performing as intended and is currently operational at the customer site.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Common Device Name: RL 1265
• 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: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 19110893
• Report Number: 3002637618-2024-00035
• Device Sequence Number: 12851902
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male