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

Catalog Number 03260763160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.The retention material of test strip lot 362550 was measured on a retention cobas u 411 analyzer and a urisys 1800 analyzer with native urine and a nitrite dilution series.The measurements showed no false positive results and showed no abnormalities.

Event Description

The initial reporter stated they received discrepant nitrite results for two patient samples tested with chemstrip 10 md test strips on chemstrip 101 urine analyzer serial number (b)(4).The event occurred on an unknown date in (b)(6) 2019.Both patient samples had positive nitrite results when tested using the test strips on the chemstrip 101 analyzer.The samples were sent to the laboratory where they were tested using an unknown method, resulting with negative nitrite values.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9191430
• MDR Text Key: 217147325
• Report Number: 1823260-2019-03729
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 03260763160
• Device Lot Number: 36255001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1