MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 2400 CASSETTE [400 TESTS]; URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM

Model Number URISYS 2400 CASSETTE

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

The cassette was requested for investigation, however, the cassette has been used up and is not available to return.

Event Description

The initial reporter complained of false positive results for 2 patients tested for nitrites on a urisys 2400 automated urine analyzer.Both patients had positive results for nitrites on the 2400 analyzer.The customer repeated the tests by dipstick and the results for both patients were negative.Patient 2 is a (b)(6) female weighing (b)(6).The results in question were not reported outside of the laboratory.The negative results were believed to be correct and were reported outside of the laboratory.The urisys 2400 analyzer serial number was (b)(4).

Manufacturer Narrative

Retention material was tested on a retention analyzer, and no abnormalities were seen.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: URISYS 2400 CASSETTE [400 TESTS]
• Type of Device: URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9438186
• MDR Text Key: 219765575
• Report Number: 1823260-2019-04335
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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 Expiration Date: 05/31/2020
• Device Model Number: URISYS 2400 CASSETTE
• Device Catalogue Number: 03012557061
• Device Lot Number: 40790200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT 2 - INSULIN.
• Patient Age: 47 YR
• Patient Weight: 100