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

Catalog Number 11008552160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event 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).

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
• Type of Device: 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
• MDR Text Key: 302429874
• Report Number: 1823260-2022-01716
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537671603
• UDI-Public: 00075537671603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1