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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
The event occurred in (b)(6).The customer¿s device was requested for investigation, but has not been returned.The investigation is ongoing.
 
Event Description
The initial reporter complained of a printer malfunction with a urisys 1100 analyzer.The customer stated the printer and the printer paper inside the analyzer burned.No serious injuries or adverse events were reported.
 
Manufacturer Narrative
The customer's device was returned for an investigation.The investigation confirmed traces of combustion and residual of soot.The investigation discovered the printer area was deformed due to heat, and the device did not turn on.The investigation found traces of urine at the drive unit, and the processor board was severely damaged by liquid.Also, the printer¿s thermo controlling chip was damaged and could not regulate the printer temperature anymore, which led to printer overheating.The investigation determined a liquid damaged the processor panel, which is consistent with product mishandling during device cleaning or routine testing.
 
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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 Key10799808
MDR Text Key215097769
Report Number1823260-2020-02784
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 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
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
Date Manufacturer Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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