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

Model Number U1100

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable nitrite and leukocyte results from the urisys 1100 urine analyzer serial number (b)(4) compared to the visual reading of the test strip.Of the data provided, only the results for nitrite were a reportable malfunction.The result from the analyzer was negative and the result from the visual exam within one minute was "trace".The patient was not treated based on the false negative result and was given antibiotics based on the visual reading.The patient was currently fine.There was no allegation of an adverse event.The test strip lot number was 26977405 with an expiration date of 31-jan-2019.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent.

Manufacturer Narrative

Additional material was requested for the investigation but not provided.The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The retention material of lot #269774 was tested on an iu urisys1100 with native urine and a nitrite-dilution-series and was visually checked.The results fulfilled the requirements and no false negative results were observed.

• 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: 7479253
• MDR Text Key: 107827594
• Report Number: 1823260-2018-01315
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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: 03617556001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 73