MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 5-TEST HC 10 STR.; URINE TEST STRIPS

Catalog Number 11896954176

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned positive nitrite and leucocytes results for 1 patient tested with urine on the combur-5 test hc test strip.The result for nitrite is a reportable malfunction.The nitrite result was "positive" on the combur-5 test strip.The result from an unknown device in surgery was "negative." no specific event details or results could be provided by the reporter.The "positive" results were reported to the patient or medical personnel.There was no allegation that an adverse event occurred.The test strips were requested for investigation.

Manufacturer Narrative

The customer returned 1 vial containing 2 test strips for investigation.Since only 2 strips were returned for investigation, completed functions testing could not be performed.The investigation of the customer¿s material and the retention material showed no abnormalities and no signs of discoloration.The retention material showed no false-positive results.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COMBUR 5-TEST HC 10 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8585826
• MDR Text Key: 144274314
• Report Number: 1823260-2019-01713
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 11896954176
• Device Lot Number: 35021301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1