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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 BLOOD GAS ANALYZER; RL 1265
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 BLOOD GAS ANALYZER; RL 1265 Back to Search Results
Catalog Number 10321852
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/21/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Siemens reviewed the data files provided by the customer.The ca++ ready sensor was not available for internal investigation.The customer is running a high number of patient samples daily.From the limited data available, diagnostic information showed that sensor deproteinization and conditioning maintenance was not performed for at least 20 consecutive days despite the number of blood samples.The root cause for the discordant calcium samples is not known.
 
Event or Problem Description
The customer reported discrepant ionized calcium results on two patients between two rl 1265 instruments.There was no report of injury due to this event.
 
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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 Key7362955
Report Number3002637618-2018-00035
Device Sequence Number128388
Product Code CHL
UDI-Device Identifier00630414515571
UDI-Public00630414515571
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K073537
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 03/21/2018
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 Number10321852
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/05/2018
Initial Report FDA Received Date03/22/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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