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

Model Number COMBUR-10-M

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

After calibration, there were no more discrepancies with nitrite results.This event occurred in (b)(6).

Event Description

The initial reporter stated that they have received discrepant high results for an unspecified number patient samples tested for nitrites on a cobas u 411 analyzer.No incorrect results were reported outside of the laboratory.The reporter stated that they tested 142 urine samples per day over a 6 day period using the same test strip lot number.When testing the samples on the u 411 analyzer, the nitrite results will be positive.When running test strips manually on these samples, the visual reading is negative for nitrite.No adverse events were alleged to have occurred with the patients.The serial number of the u 411 analyzer is (b)(4).The reporter's product was requested for investigation.

Manufacturer Narrative

Expiration date was updated.The retention material, lot 37378000, was measured on investigation unit urisys 1800 and u 411 analyzer with 0-native urine and a nitrite-dilution-series and was visually checked.The results of the measurements fulfill the requirements.No false positive results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COMBUR-10-M 100 STR
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8711688
• MDR Text Key: 148415169
• Report Number: 1823260-2019-02243
• Device Sequence Number: 1
• Product Code: JMT
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: COMBUR-10-M
• Device Catalogue Number: ASKU
• Device Lot Number: 37378004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1