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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 601 URINE ANALYZER; AUTOMATED URINE ANALYZER

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ROCHE DIAGNOSTICS COBAS U 601 URINE ANALYZER; AUTOMATED URINE ANALYZER Back to Search Results
Model Number U 601
Device Problem Patient Data Problem (3197)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Event Description
There was an allegation of a software issue for the cobas u 601 urine analyzer.The alleged issue was that a sample barcode id was incorrectly read.Sample b displayed sample a's barcode and another set of results.Sample a had the correct barcode id and results.The barcode id was not read correctly for sample b.The results were manually checked and were not reported outside of the laboratory.The software version is 2.2.10.
 
Manufacturer Narrative
The investigation found that only two tubes were placed in the rack at positions 3 and 4.There were several "warning order" warnings on the date of the event.The "warning order" error indicates errors occurred during processing of sample orders.Possible causes for the error are some sample orders could not be processed because there is not enough sample in the tube for the selected test profile, hardware errors occurred during processing of sample orders, or racks were transported to the output buffer before the sample processing was finished.There was also a "tube barcode cannot read" error, indicating the barcode label is missing, wrongly positioned, or damaged.The investigation reviewed data which showed that the analyzer handled the two samples and orders separately.It was also visible that the sample page was edited for the 4th tube.The investigation is ongoing.
 
Manufacturer Narrative
The developers examined the instrument's files and found that the analyzer handled the two samples and orders separately.It was visible that the sample page was edited for the 4th tube.Based on the provided information, it was consistent that the sample identification was mistakenly corrected to the third tube's barcode identification.The developers did not find a software issue.The investigation determined the event was consistent with a handling issue.No product problem was found.
 
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Brand Name
COBAS U 601 URINE ANALYZER
Type of Device
AUTOMATED URINE ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key14621705
MDR Text Key301476611
Report Number1823260-2022-01653
Device Sequence Number1
Product Code JIL
UDI-Device Identifier04015630932443
UDI-Public04015630932443
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K012397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/13/2022
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 NumberU 601
Device Catalogue Number06390498001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2022
Initial Date FDA Received06/07/2022
Supplement Dates Manufacturer Received06/20/2022
Supplement Dates FDA Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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