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

Model Number U1100

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

The customer complained of a false positive nitrite result for 1 patient urine sample tested on a urisys 1100 analyzer.At 2:40 pm, the nitrite result on the analyzer was positive.The nurse practitioner looked at the patient's urine under a microscope and the nitrite was negative.The patient's urine was not sent to the laboratory.There was no allegation of an adverse event.The patient was "stable".She was diagnosed with a urinary tract infection based on the analyzer result.The chemstrip 10 md urine strip lot was 25566401 with an expiration date of 30-nov-2018.The meter and test strips were requested for investigation.The retention material (lot 25566400) was measured on a urisys 1800 with native urine and a nitrite dilution series.The results of the measurements fulfill our requirements.No false positive results were observed.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 7888827
• MDR Text Key: 120706228
• Report Number: 1823260-2018-03193
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 75537253564
• UDI-Public: 75537253564
• 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
• Report Date: 12/17/2018

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: U1100
• Device Catalogue Number: 03617556001
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MACROBID; PHENAZOPYRIDINE; MACROBID; PHENAZOPYRIDINE
• Patient Age: 45 YR
• Patient Weight: 120