MAUDE Adverse Event Report: ROCHE DIAGNOSTICS / ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROCHE CHEMSTRIP 7; DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT)

Model Number	11008552160
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Roche urine dipstick products are giving trace protein results on a normal quality control (expected result is negative).Chemstrip 7 (product number (b)(4)) across multiple lot numbers, locations and users.Also observed in the chemstrip 10, and chemstrip 10sg product.Fda safety report id #:(b)(4).

• Brand Name: ROCHE CHEMSTRIP 7
• Common Device Name: DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT)
• Manufacturer (Section D): ROCHE DIAGNOSTICS / ROCHE DIAGNOSTICS INTERNATIONAL LTD.
• MDR Report Key: 14257493
• Report Number: MW5109456
• Device Sequence Number: 5137876
• Product Code: CDM
• UDI-Device Identifier: 00075537671603
• UDI-Public: 00075537671603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 08/31/2022
• Device Model Number: 11008552160
• Device Catalogue Number: 11008552160
• Device Lot Number: 53644502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown