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 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Calibration was acceptable.The customer ran a negative control, but it resulted with positive values.The reporter's product was requested for investigation and replacement product was sent to the reporter.The reporter performed comparison studies on the old urisys 1100 instrument and the replacement urisys 1100 instrument.This event occurred in (b)(6).

Event Description

The initial reporter stated they installed a new program chip version on their urisys 1100 analyzer serial number (b)(4).After doing this, the reporter received discrepant results for three patient samples tested with 2 lots of combur 10 ux test strips.The following parameters were affected: ph, leukocytes (leu), nitrites (nit), protein (pro), glucose (glu), ketones (ket), and erythrocytes (ery).The reporter used test strip lots 35703304 and 39664806, but did not know which lot was used for each measurement.Refer to the attachment for all patient data.Values highlighted in yellow are discrepant.Test strip lot number 35703304 has an expiration date of 31-dec-2019.The expiration date for test strip lot number 39664806 was requested, but not provided.

Manufacturer Narrative

One vial of lot 35703304 and some strips from lot 39664806 were received from the reporter.It was not possible to distinguish the strips between the two lots.The reporter also provided one vial of quality control test strips and urisys 1100 serial number ux09629433.The device and strip tray was cleaned and showed no damages.The retention materials of lot 35703300 and the customer material of lot 35703304 were visually checked and measured on an urisys 1100 analyzer and the customer urisys 1100 analyzer with native urine, a leucocyte, erythrocyte and a ketone-dilution-series.The retention material of lot 36255000 was measured on a cobas u411 and urisys 1800 with native urine and a leucocyte, erythrocyte and a ketone-dilution-series.The retention material and the customer material showed no false positive results and fulfilled the 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: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8936668
• MDR Text Key: 200825471
• Report Number: 1823260-2019-03125
• 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: 01/21/2020

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: U1100
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1