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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 False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2020
Event Type  malfunction  
Manufacturer Narrative
The customer recalibrated the instrument but the issue continued.The test strips used by the customer were requested to be returned for investigation.The investigation is ongoing.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable nitrite results for an unknown number of patient samples and quality control material from the cobas u 411 analyzer.The nitrite result for some sample would be (b)(6), but when the customer confirmed the result by manual analysis the result was (b)(6).No questionable results were reported outside of the laboratory.The test strips lot and expiration date were requested but were not provided.
 
Manufacturer Narrative
No product was returned for investigation.Retention material of the same lot was tested and showed no false positive results.The investigation did not identify a product problem.The cause of the event could not be determined.
 
Manufacturer Narrative
The strip lot number was 40759401 with an expiration date of 31-oct-2020.
 
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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 Key9621719
MDR Text Key191838009
Report Number1823260-2020-00190
Device Sequence Number1
Product Code KQO
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,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberU411
Device Catalogue Number04906969001
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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