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

Catalog Number	10321852
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed on a laboratory analyzer to confirm correct results.Siemens has requested the summary files from both rl 1265s and asked if the glucose sensor (from s/n (b)(4)) is available for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant glucose values on two rl 1265 instruments.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens internal review of the discordant glucose result is inconclusive.During the time of the discordant specimen analyses, the j-body ready glucose sensor on rl1265-18540 was experiencing noisy electrical responses on the inactive electrode.The customer indicated that both glucose sensors were discarded so the sensors could not be reviewed for physical integrity and performance.Onboard sensor use-life/age and proper sensor maintenance can influence the performance of the sensor.Root cause for the discordant glucose sample is not known.

• 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: 7453876
• Report Number: 3002637618-2018-00051
• Device Sequence Number: 1513089
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA