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 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.Two vials of test strips were received.One vial contained 92 out of 100 test strips and the second vial contained all 100 test strips, plus one additional test strip.It is asked, but it is not known if this additional test strip was placed into the vial by the customer.The retention material of lot 403929 and the customer material of lot 40392902 were visually checked.The retention material showed no discolorations or abnormalities.The customer material showed signs of discoloration on the test strips.This event occurred in (b)(6).

Event Description

The initial reporter stated they have received false positive nitrite results for an unspecified number of patient samples tested with combur 9 test strips.The test strips always result with positive nitrite results, although negative values are expected.The reporter noted they opened two vials of test strips and test strips contained within the vials had discolored nitrite test pads when compared to the color chart on the front of the vial.The reporter could not confirm if the stopper had been sitting correctly on the first vial, bud did confirm the stopper was sitting correctly on the second vial.

Manufacturer Narrative

The reason for 101 strips in a 100 strip vial is that during production, the filling amount is set to 101 to avoid under filling.The investigation could 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: 10192315
• MDR Text Key: 203139444
• Report Number: 1823260-2020-01536
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04510046040
• Device Lot Number: 40392902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1