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

Model Number 11008552160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2022

Event Type  malfunction  

Event 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
• Type of Device: DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT)
• Manufacturer (Section D): ROCHE DIAGNOSTICS / ROCHE DIAGNOSTICS INTERNATIONAL LTD.
• MDR Report Key: 14257493
• MDR Text Key: 290553865
• Report Number: MW5109456
• Device Sequence Number: 1
• Product Code: CDM
• UDI-Device Identifier: 00075537671603
• UDI-Public: 00075537671603
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1