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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U411 TEST SYSTEM; AUTOMATED URINALYSIS SYSTEM
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ROCHE DIAGNOSTICS COBAS U411 TEST SYSTEM; AUTOMATED URINALYSIS SYSTEM Back to Search Results
Model Number U411
Device Problem Patient Data Problem (3197)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer stated that a sample mismatch occurred on the cobas u 411 analyzer.The customer states that a mismatch occurred between the identifier number of the patient sample and the test strip results due to the instrument not matching the sample with the work list.The user was able to detect the issue and reprocessed the sample.No erroneous results were reported outside of the laboratory.No adverse events were alleged.
 
Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
COBAS U411 TEST SYSTEM
Type of Device
AUTOMATED URINALYSIS SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7973975
MDR Text Key126094900
Report Number1823260-2018-03723
Device Sequence Number1
Product Code KQO
UDI-Device Identifier04015630925636
UDI-Public4015630925636
Combination Product (y/n)N
PMA/PMN Number
K093555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/26/2018
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
Device Operator Health Professional
Device Model NumberU411
Device Catalogue Number04906969001
Initial Date Manufacturer Received 09/28/2018
Initial Date FDA Received10/17/2018
Supplement Dates Manufacturer Received09/28/2018
Supplement Dates FDA Received12/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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