MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Model Number U1100

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product has been requested for investigation.This event occurred in (b)(6).

Event Description

The initial reporter stated that they installed a new software version (5.71) on their urisys 1100 analyzer serial number (b)(4).The reporter noted that with the new software and combur 10 ux test strip lot number 38055301 (expiration date = 31-mar-2020), they have received false positive nitrite results for an unspecified number of patient samples.No specific patient data was provided.The reporter mentioned that if a sample is repeated several times, then the issue with false positive nitrite results disappears.

Manufacturer Narrative

The customer returned one vial of lot 38055301 chemstrip 10 md urine test strips, containing 78 of 100 test strips for investigation.The test strip show no abnormalities and no signs of discoloration.The retention material of lot 38055300 and the customer material lot 38055301 were both measured on an iu cobas u411/urisys 1800 analyzer with an nitrite-dilution-series and 0-native-urine the retention material showed no false positive results.The customer material showed no false positive results.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8944966
• MDR Text Key: 202413986
• Report Number: 1823260-2019-03148
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K033548
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U1100
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1