MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Catalog Number	03617556001
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The chemstrip urine test strips lot number is 70482004 with an expiration date of 31-jul-2024.The urine analyzer was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter complained that they received multiple questionable test results from an unspecified number of urine patient samples tested on the urisys 1100 urine analyzer.The reporter stated that they would receive multiple high results for all parameters from the analyzer, and when compared with the urine chemistry test strip results, the results did not match and the analyzer results were incorrect.The reporter stated that it would occur randomly and might be "two in a row" and then the results would be "okay" for a few tests.No questionable result was reported outside of the laboratory as they would question the results when multiple positives occurred and they would run the patient sample until they got a result that matched the visual reading; they would also receive an error "e2 wrong strip".The reporter was not able to provide specific examples of parameters with questionable results.
Additional Manufacturer Narrative
The customer stated that they did not have any issues with qc.The urine analyzer (without tray and strips) was received for investigation.The investigation was not able to reproduce the event.The investigation disassembled the urine analyzer and no issues were noted.The customer stated that they would receive multiple high results for all parameters from the analyzer.When compared with the urine chemistry test strip results, the results did not match and the analyzer results were incorrect.The reporter also stated they would also receive an error "e2 wrong strip".Product labeling states: "values obtained are implausible when compared with those from visual evaluation cause: test strip incorrectly positioned or uncharacteristic test pad colors.The wrong test strip may have been used.Action: repeat the measurement with a new test strip.Follow the directions carefully and ensure the test strip is correctly inserted (see section 6.3).Repeat calibration if necessary.Repeat the measurement.If the problem persists, perform a quality control (see section 6.2).Cause: electromagnetic interference from other devices (see section 4).Action: remove external sources of interference, if there are any." "e2 wrong strip! cause: the test strip used is different from the one for which the analyzer has been programmed ("chem 10" test strip).Action: press the start button.Repeat the measurement with the type of strip for which the analyzer has been programmed." the investigation noted that the urine analyzer was over five years old.A replacement urine analyzer was sent to the customer.The investigation did not identify a product problem.

• Brand Name: URISYS 1100
• Common Device Name: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18854832
• Report Number: 1823260-2024-00687
• Device Sequence Number: 14287320
• Product Code: KQO
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K033548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Catalogue Number: 03617556001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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