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 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter stated they received a discrepant nitrite result for one patient sample tested using urisys 1100 analyzer serial number (b)(4).The patient sample initially resulted with positive nitrite values when tested using the urisys 1100 analyzer and when visually reading the test strip.The sample was sent to the laboratory where it was tested using an unknown method, resulting with a negative value for nitrite.

Manufacturer Narrative

The lot number provided by the customer does not exist.The customer could not clarify the correct lot number.A retention lot, 34762800, which was the closest match that could be found, was measured with a cobas u411 / urisys 1800 analyzer.The results fulfill manufacturer¿s requirements.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: 8982474
• MDR Text Key: 203820780
• Report Number: 1823260-2019-03255
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 3472802
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1