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

Model Number U1100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

A licensed vocational nurse complained that the 1st urine strip dip results for 1 patient were different than the 2nd and 3rd urine strip dip results when tested for leukocytes, nitrites, erythrocytes, specific gravity, and ph.The erythrocytes results were erroneous.The initial erythrocytes result was 50 ery/ul.The 2nd and 3rd run results were both negative.These results were reported to the doctor who ordered a urine culture based on the discrepant results.The results from the urine culture are not known.No adverse event occurred.The chemstrip 10 md urine test strip lot number was 20526602 with an expiration date of 11/30/2016.It was noted that after these results, the customer attempted to calibrate the instrument and received an error message.The tray was cleaned, they waited 48 hours and calibrated again and they still received the error message.The instrument and test strips were requested for return.

Manufacturer Narrative

Retention samples of the same lot that customer used were tested.No false negative results were observed.

Manufacturer Narrative

The customer returned the test strips used during the event along with meter serial number (b)(4).The customer's test strips were tested on the customer's meter and a meter used at the investigation site.No false negative results were observed.The results of the measurements fulfill the requirements.It was noted that the tray on the customer's meter was very dirty and a small piece of a test strip was in the bottom of the tray.This could cause the test strip to be positioned incorrectly which could contribute to errors and the misreading of strips due to poor light reflection.The root cause of the issue was likely due to incorrect customer handling and a dirty tray.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5456358
• MDR Text Key: 39425997
• Report Number: 1823260-2016-00206
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: U1100
• Device Catalogue Number: 03617556001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 85