MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 2400; AUTOMATED URINE ANALYZER

Model Number U2400

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event occurred in: (b)(6).

Event Description

The customer complained of false positive nitrate results for multiple urine patient samples tested on a urisys 2400 analyzer.Erroneous results for 5 patient samples were reported outside of the laboratory to a doctor.The customer noticed that the transport plate was getting very dirty with urine resulting in the erroneous results.After cleaning the transport plate and changing the strip cassette, there have no further occurrences of false results.The urisys cassette strip lot was 23672200 with an expiration date that was not provided.

Manufacturer Narrative

The retention material of strip lot #23672200 was measured on an urisys 2400 with native urine and a nitrite-dilution-series.The results of the measurements meets requirements.No false positive results were observed.The dirty tray could not be excluded as a possible cause of the event.The investigation was unable to find a definitive root cause.

• Brand Name: URISYS 2400
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7333430
• MDR Text Key: 102731355
• Report Number: 1823260-2018-00785
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K012397
• 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: 05/29/2018

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: U2400
• Device Catalogue Number: 03051323001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1