MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 10 MD URINE TEST STRIPS

Catalog Number	03260763160
Medical Device Problem Codes	False Negative Result (1225); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The urisys 1100 urine analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable chemstrip 10 md urine test strips leukocytes result from the urisys 1100 urine analyzer.The operator noted seeing a positive leukocyte result as they were loading the test strip on the 1100 analyzer.The 1100 analyzer gave a negative leukocyte result.The same sample was re-tested on (b)(6) 2025 and read visually with a result of 2+ leukocytes.A urine culture was sent out, and the results were negative.
Additional Manufacturer Narrative
During the investigation, the retention material of lot 75515400 and the customer material of lot 75515403 were both measured on the customer urisys 1100 analyzer us s/n (b)(6), an iu urisys 1100 analyzer with 0-native-urine, an erythrocytes-dilution-series, and a leucocytes-dilution-series according to the testing-plan.No abnormal results were observed.The customer material passed all of the checks during production and was released without restrictions.No product issue was found.The available information is consistent with the strip not being inserted correctly into the tray and the instrument measuring between the test pads.

• Brand Name: CHEMSTRIP 10 MD URINE TEST STRIPS
• Common Device Name: URINE TEST STRIPS
• 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: 21752323
• Report Number: 1823260-2025-00981
• Device Sequence Number: 18192880
• Product Code: LJX
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K032437
• 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): 05/28/2025

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 03260763160
• Device Lot Number: 75515403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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