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

Model Number	D051188
Medical Device Problem Codes	Incorrect Measurement (1383); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The urine test strip lot number is 1080097404 with an expiration date of 30-nov-2025.It was reported the customer received an e-5 alarm during a calibration issue.The test strips are not available for investigation as they have been discarded.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable negative protein results for approximately 6 patient samples on a urisys 1100.It was alleged that the visual results were 2 color blocks out (positive).
Additional Manufacturer Narrative
Sections d1-d4, g1, and g4 were updated.The retention material for lot 80097400 was measured on an iu urisys 1100 analyzer equipped with sw-v.6.71 and by visual reading with 0-native-urine and a protein-dilution-series according to testing-plan.The testing showed no abnormal results.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 21347047
• Report Number: 1823260-2025-00386
• Device Sequence Number: 7740849
• Product Code: LJX
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/19/2025

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: 11/30/2025
• Device Model Number: D051188
• Device Catalogue Number: 03260763160
• Device Lot Number: 80097404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/19/2025
• 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