MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1240 BLOOD GAS ANALYZER; RL 1240

Model Number	10321840
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Pregnancy (3193)
Date of Event	07/01/2020
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.The data logs have been received for investigation.The customer stated, for the first and second samples, they did not do the necessary check of the sample to assure the sample is in the correct position.
Event or Problem Description
The customer reported discrepant ph values on the rl 1240 blood gas analyzer.The mother has undergone a caesarean section.The customer was asked to confirm the unnecessary treatment was not performed because of the discrepant results.The customer stated they used other diagnostic methods in addition, such as cardiotocography, a fetal monitor.The customer stated the baby was born in good condition.
Additional Manufacturer Narrative
Siemens has completed the investigation.After reviewing the samples in question, it can be confirmed that the micro samples were not positioned over the pco2 and po2 sensors as they recovered close to ambient air.The observed ph discrepancy is most likely caused by blood not being positioned over the ph sensor.Micro samples on the rapid lab instruments require to be manually positioned over the reportable sensors.The instrument logs show that for the micro samples run around the time of the event, the ph, pco2 and po2 sensors were reporting in the normal range.This suggests that the sensors in question were functioning normally.

• Brand Name: RAPIDLAB 1240 BLOOD GAS ANALYZER
• Common Device Name: RL 1240
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10325956
• Report Number: 3002637618-2020-00039
• Device Sequence Number: 11485452
• Product Code: CHL
• UDI-Device Identifier: 00630414515540
• UDI-Public: 00630414515540
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: Health Professional
• Device Model Number: 10321840
• Device Catalogue Number: 10321840
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/05/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1