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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 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer alleged a possible patient sample mismatch on the cobas u 411 analyzer with software version 3.3.2.The customer stated that a sample mismatch occurred during the processing of "some" samples.The results were sent to the host system.The customer reviewed the results in the host system and noted that the samples did not match the sample characteristics.The customer repeated the tests and confirmed the correct result by microscopy.There was no allegation that an adverse event occurred.Investigations are ongoing.
 
Manufacturer Narrative
The investigation found the customer was reading the patient sample identification number incorrectly from the barcode scanner.The investigation determined the issue was due to an operator error and there was no malfunction of the device.
 
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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 Key8358212
MDR Text Key136807744
Report Number1823260-2019-00729
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
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
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 Received01/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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