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 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of questionable nitrite, protein, leukocytes, and erythrocytes results for one patient urine sample on a urisys 1100 urine analyzer.Of the data provided by the nurse, only the results for the nitrite were a reportable malfunction for 2 patient urine samples.For patient 1 the nitrite result from the meter was negative and the visual result was positive.On (b)(6) 2018 for patient 2, the nitrite result from the meter was negative and the visual result was positive.The nurse did not trust results from the meter.The treatment of antibiotics for both patients was based on the visual results.Neither patient was harmed due to the erroneous results.There was no allegation of an adverse event.The calibration and qc were acceptable.The chemstrip 10 md urine strip lot was 25566401 with an expiration date of 30-nov-2018.The suspect meter and strips were requested to be returned for investigation.

Manufacturer Narrative

The retention material (lot 25566400) was measured on a retention urisys1100 with zero native urine and a nitrite dilution series and was visually checked.The results of the measurements fulfill our requirements.No false negative results were observed.

Manufacturer Narrative

The retention material (lot 25566400) and the customer material (lot 25566401) were measured both on a retention urisys1100 analyzer and on the customer urisys 1100 analyzer with native urine and a nitrite dilution series and was visually checked.The results of the measurements fulfilled the requirements.No false positive results were observed.Further investigation was unable to find a definitive root cause.

• 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: 7491767
• MDR Text Key: 108166966
• Report Number: 1823260-2018-01405
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1