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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265; RL 1265
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265; RL 1265 Back to Search Results
Catalog Number 10321852
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2014
Event Type  malfunction  
Event Description
Customer indicated that two patient samples were run when lactate automatic quality control (aqc) result was out of range.
 
Manufacturer Narrative
Based on the siemens investigation data, the sensor under-recovered highgl(quality control material) on 7/8/2014 which is the end of life marker for glucose and lactate.The lactate sensor should have been replaced on 7/8/2014 but was not replaced until 7/10/2014 after the aqc level 1 under-recovered.Customer should not have run patient samples when automatic quality control (aqc) result for lactate was out of range.The event is occurred due to an operator error.
 
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Brand Name
RAPIDLAB 1265
Type of Device
RL 1265
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown 10591
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key3981038
MDR Text Key4632074
Report Number1217157-2014-00109
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number10321852
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/09/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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