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

Model Number U2400

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) found the gripper fingers were corroded and sticking causing the test strips to not feed correctly.The gripper fingers and test strip guides were replaced.The test strips feed successfully and the customer ran calibration and qc successfully.Following the service visit, the customer complained of an additional patient sample with a false positive nitrite result.The result was compared with a dipstick strip test and the result was negative.The investigation is ongoing.

Event Description

The initial reporter complained of false positive results for 2 patient samples tested for nitrites on a urisys 2400 urine analyzer.The positive results for both patients were reported outside of the laboratory but were not finalized until confirmation testing was performed.Both samples were manually re-run by dipstick testing and were also reviewed microscopically and found to be negative.Corrected reports were issued to reflect the negative results.The urisys 2400 cassette reagent lot number was 40790200 with an expiration date of 31-may-2020.

Manufacturer Narrative

No customer material was received for investigation.The retention material of lot 40790200 was measured on an urisys 2400 analyzer with 0-native-urine and a nitrite-dilution-series according to the testing plan.No false positive results were received.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: URISYS 2400
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9384272
• MDR Text Key: 219763285
• Report Number: 1823260-2019-90264
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 08430215045466
• UDI-Public: 8430215045466
• 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: 01/10/2020

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: U2400
• Device Catalogue Number: 03051323001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1