MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U411 TEST SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number U411

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The analyzer was cleaned in all areas, including the measurement area.The reference strip was changed.A new calibration was performed.After these actions, the patient and quality control results recovered correctly.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 10 m test strips on a cobas u 411 analyzer.The affected patient samples will have positive nitrite results when tested on the u 411 analyzer, but the microscopic examination results do not agree with the positive nitrite values.The issue also occurs with quality control material.The combur m 10 test strip lot number was 41516505, with an expiration date of 31-jul-2020.

Manufacturer Narrative

The retention material of lot 415165 was measured on a retention cobas u411 and by visual reading with native urine and a nitrite dilution series.The results are comparable.

• Brand Name: COBAS U411 TEST SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10025360
• MDR Text Key: 216136544
• Report Number: 1823260-2020-01177
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K093555
• 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: 05/26/2020

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 Model Number: U411
• Device Catalogue Number: 04906969001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1