MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-5-TEST 100 STR; URINE TEST STRIPS

Catalog Number 11893467255

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of photographs of the affected vials and test strips, a pink liquid was observed on the outside of one of the test strip vials and on one of the test strips.The nitrite test pads of the strips appeared slightly pink.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for an unspecified number of patient samples tested with combur 5 test strips.The issue only started happening recently.The affected patient samples have false positive nitrite results when tested using the test strips and visually reading the results from the strip.No specific examples of affected patient samples were provided.The reporter states the issue occurred when using two different vials of test strips.The reporter stated there were no cracks in the test strip containers/vials.The nitrite block on the test strip was slightly pink before testing.

Manufacturer Narrative

Retention material was checked and showed no abnormalities and no signs of discoloration.The customer did not return material for investigation, no further investigation is possible.Photographs of the customer's test strips showed the test strip was discolored before use.This can cause the false positive nit results.It is consistent with the strip vial not being closed correctly or opened for too long.

• Brand Name: COMBUR-5-TEST 100 STR
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9165897
• MDR Text Key: 217916763
• Report Number: 1823260-2019-03613
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 11893467255
• Device Lot Number: 39664402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1