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 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated she received questionable results for leukocytes, nitrites, protein, and blood for multiple patients.The customer recalibrated and repeated controls which were all in range.The customer repeated all tests and reported the results from the visual readings.The customer could not provide specific data, but claimed there were false negative nitrite results that were positive when read visually and false negative blood results that were different more than two color blocks when read visually.The customer was unsure if any medical treatment was delayed for any of the patients.There was no allegation of an adverse event.The strip lot number was 21650703 with expiration date 30-jun-2018.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent to the customer.

Manufacturer Narrative

Retention material of lot #216 507 00 was measured on an iu (b)(4) with native urine, an erythrocyte dilution series, a leukocytes dilution series, a protein dilution series, and a nitrite dilution series and was visually checked.The results were within specification.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.No customer material was received for further investigation.

• 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: 7246957
• MDR Text Key: 99791422
• Report Number: 1823260-2018-00353
• 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: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• 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?: No
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1