MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-9-TEST; URINE TEST STRIPS

Catalog Number 04510046040

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Reporter occupation is purchasing department for wholesaler.The test strips were requested for investigation.

Event Description

The initial reporter complained that nitrite results are always false positive when testing on 2 specific lot numbers of combur-9 urine test strips.The analyzer used was not provided.The lot numbers in question are: lot 40392902 with an expiration date of 30-nov-2020.Lot 39009003 with an expiration date of 30-sep-2020.No specific comparisons or repeat results were provided.

Manufacturer Narrative

The customer's test strips (lot 39009003) were returned for investigation.The retention material of lot 39009000 and the customer material of lot 39009003 were visually checked.The retention material shows no discolorations or abnormalities.The customer material show signs of discolorations on the test strips.The investigation is ongoing.Medwatch fields d10 and h3 have been updated.

Manufacturer Narrative

The customer's test strips (lot 40392902) were returned for investigation.The retention material of lot 40392902 and the customer material of lot 40392902 were visually checked.The retention material shows no discolorations or abnormalities.The customer material show signs of discolorations on the test strips.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COMBUR-9-TEST
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9756017
• MDR Text Key: 218017056
• Report Number: 1823260-2020-00565
• 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: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2020

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: 11/30/2020
• Device Catalogue Number: 04510046040
• Device Lot Number: 40392902, 39009003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/07/2020; 02/07/2020
• Supplement Dates FDA Received: 07/31/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1