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	06/11/2018
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.The requested data files have been received for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported discordant total hemoglobin results between two rl 1265s.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens evaluated the data files provided by the customer.Although full files were submitted, they appeared to be incomplete or corrupted resulting in no information available from the databases.The investigation centered on the.Csv files for rl1265-15558.At the time the sample was measured, the co-ox on system rl1265-15558 appears to have been experiencing a temporary pathlength stability issue.This manifested in thb calibration errors on the calibration that occurred 10 minutes after the sample in question.The pathlength drift affected the thb result.The pathlength stability returned to, and maintained to, expected performance within the hour.The actual root-cause as to why the thb drifted at that particular time is unknown.
Additional Manufacturer Narrative
Changed rp 500 to read rl 1265.Siemens evaluated the files provided by the customer.At the time of the discordant thb result, the co-ox on s/n (b)(4) was experiencing a short temporary period of instability.This is evident by the thb slope errors and aqc disabled thb results that occurred shortly after the whole blood measurement in question.A low frequency of thb drift errors is not uncommon, and to be expected, during the life of the rl1265.The low thb result was most likely a result of a temporary thb drift event, and the repeat calibration and drift errors posted immediately after the discordant sample, as well as no thb results for the next aqc sample all should suggest to the customer that there was a short period of thb pathlength/slide-cell adjustment.The actual root-cause as to why the thb drifted at that particular time is unknown.

• 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: 7665018
• Report Number: 3002637618-2018-00076
• Device Sequence Number: 1384387
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018

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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 08/23/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/20/2018; 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR