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

Catalog Number	03617556001
Medical Device Problem Codes	False Positive Result (1227); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for an unspecified number of patients tested with the chemistrip 10 md urine test strip on a urisys 1100 urine analyzer.The samples were initially tested on the meter, and the glucose results were positive.The meter results did not meet the patients' clinical status, as the patients were not sick and with no symptoms.In addition, the results did not correlate with the visual reading of the test strip.The patients were tested on an accu-chek inform meter, and the glucose results were negative.No exact results were provided.The customer was not sure whether the urisys 1100 result or the visual result was correct.
Additional Manufacturer Narrative
The chemistrip 10 md urine test strips' lot number was 80097404 with an expiration date of 30-nov-2025.The qc and calibration were acceptable.The meter and test strips were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Section d9 was updated.One urisys 1100 urine analyzer us with a serial number of (b)(6) was received for investigation.No strips were returned.The analyzer showed no signs of damage and no abnormalities.The retention material of lot number 80097400 was measured on the customer's urisys 1100 analyzer and on an iu urisys 1100 analyzer with 0-native-urine, a leukocytes-dilution-series, a glucose-dilution-series, a protein-dilution-series, and an erythrocytes-dilution-series.The investigation identified the following: no false positive results were observed.No abnormal results were observed.All materials fulfill the requirements.Product release/stability review: lot number 80097404 had passed all checks during production steps and was released without restrictions.The investigation did not identify a product problem.The cause of the event was consistent with a handling issue at the customer's site (the strip end was not completely pushed under the clip of the instrument).

• Brand Name: URISYS 1100 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22018979
• Report Number: 1823260-2025-01486
• Device Sequence Number: 18489461
• Product Code: KHE
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/20/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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