MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 2400; AUTOMATED URINE ANALYZER

Model Number U2400

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, the customer experienced issues with qc results for leukocytes and glucose on the urisys 2400 urine analyzer.The customer cleaned the transfer base and reference pad, and then performed a calibration which was successful.The customer noted that the transfer base was highly faded and silver.The customer had used a black marker to fill in the transfer base.The customer repeated qc with the same failing results and then discovered that the probe was bent.The customer stated they had tested 50 urine samples on (b)(6) 2016 and they were all negative for leukocytes.The customer manual retested the samples on (b)(6) 2016.Of these samples, the results for 11 were found to be false negative.The manual readings for these samples were 1+ (100 leu/microliter) or 2+ (500 leu/microliter).The customer also noted there were issues with the initial erythrocyte and nitrite results when compared to the manual readings.For erythrocytes, the initial results for an unknown number of samples were negative and the manual results were 10 ery/microliter or 50 ery/microliter.The erroneous results were reported outside the laboratory.The results from the manual readings were believed to be correct and corrected reports were sent.The patients were not adversely affected.The test strip lot number was 15228000 with an expiration date of 05/2017.The field service representative found there was a bent sample nozzle and replaced it, the nozzle sensor, and bed assembly.The customer ran successful qc.

Manufacturer Narrative

The customer test strip material was not available for further investigation.The test strip retention material of lot 15228000 was measured with 0-native urine and a leukocyte- dilution series on an iu urisys 2400 device.All results of the measurement fulfill our requirements and no false negative results were observed.No other complaints similar to this issue have been received for this lot of test strip material.The investigation determined the issue with the sample nozzle found by the field service representative was the root cause of the event.

• Brand Name: URISYS 2400
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6118609
• MDR Text Key: 60649526
• Report Number: 1823260-2016-01827
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

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: U2400
• Device Catalogue Number: 03051323001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• 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