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

Model Number	U 601
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter alleged a possible sample mismatch issue with a cobas u601 urine analyzer.The sample ids affected were (b)(6) when the analyzer was in "serial number" mode.The sample tube was not detected by the u601 analyzer but was detected by the u701 analyzer.The results from sample tube id (b)(6) appeared to be from a sample tube with id (b)(6).The patient results do not correspond to the sample ids on the sample tubes.The operator was monitoring the analyzer and noticed that some sample tubes were not detected by the u601 analyzer and deleted the sample numbers.No incorrect results were reported outside of the laboratory.
Additional Manufacturer Narrative
The data provided for investigation indicate there was an issue with the tube detection sensor and tube with id (b)(6) was not detected.At the time the sample tubes with ids (b)(6) were measured, the default test profile was for the u601 instrument only.If the u601 instrument does not detect the sample tube but the u701 module does, an order is created for the u601 instrument only (since it is the only test profile.) the sample tube with id (b)(6) was detected normally by the u601 instrument and the measurement was started but the sample tube with id (b)(6) was not detected by the u601 instrument.Sample tube with id (b)(6) was detected later by the u701 instrument and an order for the u601 instrument was created.There was no patient sample mismatch as sample tube with id (b)(6) was not measured; there was a mismatch between the sequence number generated by the instrument and the sequence number assigned to the tubes by the operator.The issue was resolved at the customer site by adjusting the tube detection sensor.The sensor itself was working correctly.The investigation determined the event was due to an incorrectly adjusted tube detection sensor.

• 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: 12453674
• Report Number: 1823260-2021-02655
• Device Sequence Number: 3332611
• Product Code: JIL
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/09/2021

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: 08/20/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/09/2021
• 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