MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Model Number URISYS 1100

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The analyzer and test strips were requested for investigation.

Event Description

The initial reporter complained of false positive nitrite results on urisys 1100 analyzer serial number (b)(4).The customer alleged receiving false positive nitrite results using combur 10 test strip lot 39664803.When the customer changed to a different strip lot, they no longer had false positive nitrite results.No incorrect results were reported outside of the laboratory.

Manufacturer Narrative

The customer was sent new test strips, lot 40396202 with an expiration date of 31-aug-2020.With the new test strips the customer continued to receive false positive nitrite results.The urisys 1100 analyzer serial number (b)(4) software version is 5.71.The customer is now suspecting an issue with the instrument and not the test strips.The customer inserted a new test strip tray and the issue has not been resolved.The original test strip lot was 39664803.Applicable fields of section d, suspect medical device and field g5, 510k were updated.

Manufacturer Narrative

The customer provided one vial of chemstrip 10 md lot 39664803 with 50 of 100 ts remaining for investigation.The test strips show no abnormalities.During the investigation, the retention material of lot 39664800 and the customer material lot 39664803 were both measured on an iu cobas u411 / urisys 1800 with 0-native-urine and were checked by visual reading a with 0-native-urine and a nitrite-dilution-series.The urisys 1100 analyzer international, s/n (b)(6), with software-version 5.71, without test strip tray was also returned for investigation.The device was clean and showed no damages.An additional tray c5 was received which was slightly contaminated.The customer urisys 1100 analyzer ux09644087 was measured with another strip lot #43065200 with 0-native urine.The additional received tray c5 was installed on an iu urisys 1100 analyzer and was also measured with 0-native-urine.The investigation determined the customer material (analyzer, strips and tray) showed no false positive results and fulfill our requirements.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: URISYS 1100
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9427956
• MDR Text Key: 219209152
• Report Number: 1823260-2019-04309
• 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,Followup
• Report Date: 04/10/2020

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: URISYS 1100
• Device Catalogue Number: 03617548001
• Device Lot Number: 39664803
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 11/15/2019
• Supplement Dates FDA Received: 01/14/2020; 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1