MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 2400 CASSETTE [400 TESTS]; URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM

Model Number URISYS 2400 CASSETTE

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer changed the cassette, ran calibration which passed and cleaned the instrument.Qc was rerun but the issue was not resolved.The customer stopped using the instrument and is running patient samples on the clinitek instrument.The cassette was requested for investigation; however, the customer has discarded the actual cassette in use.The customer intends to send a different cassette with the same lot number for investigation.The field service engineer (fse) found a sample tube leaking in a cell.The fse replaced the tube going to the sample probe and rebuilt syringes and cleaned the system.Calibration, qc, mechanism checks and diagnostic checks were all acceptable.The instrument has been working well since the service visit.

Event Description

The initial reporter complained of qc issues and false negative results for 1 patient tested for leukocytes with the urisys 2400 cassette on a urisys 2400 automated urine analyzer with serial number (b)(4).The initial leukocytes result from the urisys 2400 analyzer was negative at 1:42 a.M.The negative results from the urisys 2400 were reported outside of the laboratory and were questioned by the physician as a uti was suspected.The physician requested a recollection of the patient sample.The new sample was run on the urisys 2400 analyzer at 5:30 a.M.And the leukocytes result was negative.The new sample was run on the clinitek instrument at 5:39 a.M.And the leukocytes result was small (1+).At 5:25 a.M.Microscopic tests were performed with the following results: wbc= 10-25/hpf, rbc=10-25/hpf, bacteria 3+.These results suggest the positive results from the clinitek instrument were correct.The first sample was run on the clinitek instrument at 5:53 a.M.And the leukocytes result was large (3+).The positive results were reported outside of the laboratory where the patient was diagnosed and treated for acute cystitis (uti).

Manufacturer Narrative

The customer material of lot 37882400 was installed on an iu u2400 analyzer and was tested with biorad quantify plus control level 2 lot 79702 and was also tested with 0-native-urine, a nitrite-dilution-series, a ketone-dilution-series, a leucozytes-dilution-series and an erythrocytes-dilution-series.The returned cassette functioned as specified.The customer material shows no false negative results.The material shows also no abnormalities and fulfills our requirements.All values met the respective target range.Based on the available data, a general reagent issue could be excluded.

• Brand Name: URISYS 2400 CASSETTE [400 TESTS]
• Type of Device: URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9122972
• MDR Text Key: 208600422
• Report Number: 1823260-2019-03452
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K012397
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: URISYS 2400 CASSETTE
• Device Catalogue Number: 03012557061
• Device Lot Number: 37882400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR