MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 7; URINE TEST STRIP

Catalog Number	11008552160
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
This report was initially provided to roche by fda via medwatch (b)(4).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).
Additional Manufacturer Narrative
The customer dropped the qc solution onto the test pads, tipped the strip allowing the excess solution to run off the sides, and then read it.The recommended technique is to dip the strips into the qc solution.The retention material of lot 53644500, 55018600, and 51951500 were investigated and measured by visual reading.No false positive results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP 7
• Common Device Name: URINE TEST STRIP
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14676398
• Report Number: 1823260-2022-01716
• Device Sequence Number: 12032945
• Product Code: JIL
• UDI-Device Identifier: 00075537671603
• UDI-Public: 00075537671603
• Combination Product (Y/N): N
• 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): 08/03/2022

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 Catalogue Number: 11008552160
• Device Lot Number: 53644502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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