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

Model Number	U 601
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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.

• Brand Name: COBAS U 601 URINE ANALYZER
• Common Device Name: 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 Key: 14621705
• Report Number: 1823260-2022-01653
• Device Sequence Number: 4347156
• Product Code: JIL
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K012397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: U 601
• Device Catalogue Number: 06390498001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown