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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER
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ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER Back to Search Results
Model Number U1100
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
The reporter's product was requested for investigation.This event occurred in (b)(6).
 
Event Description
On (b)(6) 2019, the initial reporter stated they received a positive nitrite value for a proficiency sample when tested with an unknown test strip on a urisys 1100 analyzer.The result for this sample should have been negative.A new test strip tray was sent to the reporter and the reporter was asked to monitor patient values.Over a two month period of time, the reporter observed result discrepancies for six patient samples.Four patient samples had negative nitrite results when tested on the urisys 1100 analyzer, but cultures performed on these samples were positive.Two patient samples had positive nitrite results when tested on the urisys 1100 analyzer, but cultures performed on these samples were negative.
 
Manufacturer Narrative
No material was provided for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
URISYS 1100
Type of Device
AUTOMATED URINE ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9490942
MDR Text Key218687980
Report Number1823260-2019-04462
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
PMA/PMN Number
K033548
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 02/13/2020
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 NumberU1100
Device Catalogue Number03617548001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received12/05/2019
Supplement Dates FDA Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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