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

Model Number U1100

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2016

Event Type  malfunction  

Event Description

The customer questioned low results for 1 patient tested for leukocytes, glucose, erythrocytes, protein and specific gravity on a urisys 1100 instrument.The meter results were being compared to visual results.Based on the data provided, the glucose and erythrocytes results were erroneous.The customer reported the visual results to the physician.The customer is not sure if the meter or the visual results are correct.It is not known if erroneous results were reported outside of the laboratory.The glucose result from the meter was 100 mg/dl.The visual result was 1000 mg/dl.The erythrocytes result from the meter was negative.The customer provided 3 visual results of trace, 50 ery/ul and 250 ery/ul.No adverse event occurred.The patient is feeling fine.The chemstrip urine test strips lot number was 20339002 with an expiration date of 10/31/2016.The suspect product has been requested for return.

Manufacturer Narrative

The retention material of the same lot that the customer used were tested.The results of all measurements fulfill requirements.No false results were observed.

Manufacturer Narrative

The customer returned the instrument and the test strips.No noticeable defects were observed.The returned test strips and the retention test strips were tested on the customer's instrument, a retention urisys 1100 and a retention urisys 1800 instrument.All results were acceptable according to the testing plan.The customer's results, the results from the urisys 1100 used during the investigation and the visual results were all comparable.No additional, similar customer complaints have been received for lot number 20339002.A specific root cause could not be identified for this event.Factors such as the value offset of the device and stronger dabbing of the test strips can potentially cause values to drift in the same direction, and, in very rare cases, produce borderline results.The borderline results are not typically higher than one color block difference.

• 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: 5663983
• MDR Text Key: 45427706
• Report Number: 1823260-2016-00654
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• 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