MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1265 BLOOD GAS ANALYZER; RL1265

Model Number	10321852
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional 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.No patient treatment was affected due to the discrepant results.Siemens has requested instrument log files for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported several discrepant thb results on their rl1265 instrument compared to retesting of different samples on a non-siemens hematology instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
The customer was not able to provide instrument files.Without files, siemens cannot perform a proper investigation and therefore the root cause of the customer issue cannot be determined.Siemens has provided the customer with instrument comparison studies and service has reiterated the importance of sample handling.The customer has declined to perform their own internal correlation study for siemens to evaluate.However, they have accepted the recommendations for sample handling and pre-analytics.The cause of this event is unknown.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Common Device Name: RL1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10461496
• Report Number: 3002637618-2020-00045
• Device Sequence Number: 2147284
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: Other
• Device Model Number: 10321852
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1