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

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.

• 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 Key: 14621705
• MDR Text Key: 301476611
• Report Number: 1823260-2022-01653
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• 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 Number: U 601
• Device Catalogue Number: 06390498001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/13/2022
• 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 Number: 1