MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-10-TEST 100 STR.; URINE TEST STRIPS

Catalog Number 04510062171

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable false positive nitrite results for 3 to 4 children patient urine samples when testing with combur-10-test strips.The specific number of patients was not provided.The customer stated the bottle was "opened 10 years ago".Verification on how long the bottle of test strips has been open was requested but has not been provided.If the lot number provided by the customer is correct the test strips were manufactured in january 2018.The nitrite results were positive.The expected results and the results with a different strip lot were negative.The different strip lot was not provided.There was no allegation of an adverse event.The suspect device was requested to be returned for investigation.

Manufacturer Narrative

The correct length of time the bottle strips was opened was provided as 10 months.

Manufacturer Narrative

The retention material of lot 32222100 was visually checked with native urine, a nitrite dilution series and a leucocytes dilution series.The results of the measurements fulfill our requirements.No false postive results were observed.

Manufacturer Narrative

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

• Brand Name: COMBUR-10-TEST 100 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8085293
• MDR Text Key: 129196694
• Report Number: 1823260-2018-04362
• 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,Followup
• Report Date: 01/07/2019

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: 09/30/2019
• Device Catalogue Number: 04510062171
• Device Lot Number: 32222102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 10/31/2018; 10/31/2018; 10/31/2018
• Supplement Dates FDA Received: 12/04/2018; 12/17/2018; 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1