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 Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has received the data logs provided from the customer for investigation.The customer stated that they changed the measurement cartridge and the instrument is operational.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant total hemoglobin results from two rl 1265 instruments and a non-siemens hematology analyzer.There was no report of injury due to this event.
Additional Manufacturer Narrative
Contact office - name/address: contact information updated.Siemens reviewed the data provided by the customer.The thb values for the patient samples in question appears valid.No interfering substances were identified, and no co-ox diagnostic errors were flagged on the day the sample was run.There is no suggestion that the co-ox module was malfunctioning.The thb value for the patient sample in question may have differed due to the separate patient draws and sample handling.If the samples are not well mixed at the time of the test, the blood cells will settle and give a different result when compared to a well-mixed sample.The root cause of the discrepant thb results cannot be determined.

• 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: 8408647
• Report Number: 3002637618-2019-00030
• Device Sequence Number: 13531034
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: FP
• 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,Followup
• Report Date (Section B): 06/17/2019

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
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR