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 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.

Event Description

The initial reporter stated they received discrepant nitrite results for three patient samples tested with chemstrip 10 md urine test strips on urisys 1100 analyzer serial number (b)(4).One patient sample tested on (b)(6) 2019 resulted with a positive nitrite value when the test strip is tested on the urisys 1100 analyzer.When reading the same test strip visually, the nitrite value appears to be negative.Two patient samples tested on (b)(6) 2019 resulted with a positive nitrite value when the test strip is tested on the urisys 1100 analyzer.When reading the same test strips visually, the nitrite values appeared to be negative.The reporter tried testing water with the same test strips twice and each time, the water had a positive nitrite value when the test strip was measured with the urisys 1100 analyzer.The test strips appeared to have a negative nitrite values when read visually.The reporter opened a new vial of the same test strip lot number and tried testing the water again.Both the analyzer measurement and visual reading of the test strip had negative nitrite values.

Manufacturer Narrative

The customer sent the u1100 analyzer s/n ux09662560 and one vial of chemstrip 10 md urine test strips lot 35703302 with 8 of 100 test strips remaining for further investigation.The returned customer strips were discolored and the lid of the vial showed signs of humidity.The issue is consistent with the vial not being closed correctly or being opened too long.The retention material shows no abnormalities.

Manufacturer Narrative

The customer's urisys 1100 analyzer was clean and showed no damages.The customer's urisys 1100 analyzer was measured with retention test strip lot number 43065200 with native urine.The analyzer showed no false positive results and fulfilled requirements.

• 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: 9127888
• MDR Text Key: 217075354
• Report Number: 1823260-2019-03472
• 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,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 35703302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1