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 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained that the blood, leukocytes, and protein urine results from a urisys 1000 urine analyzer were false negative.The customer stated they were receiving false negative results from somewhere from 10 to 12 urine samples a day.The customer did not know a specific day that this started to happen, but said it has been a daily problem for the last month.The customer could not provide specific data.The customer stated that the chemstrip 10 md urine test strips that were run through the meter would produce negative results according to the meter for blood, protein, and leukocytes, but when visually comparing the same strips after the meter testing, the strips showed positive results for blood, protein, and leukocytes.The customer stated that the blood results showed sometimes more than a 2 block color change, while the protein and leukocytes would show more than a 1 or 2 block color change.The erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The chemstrip 10 md urine test strips lot number was 21650703 with expiration date 30-jun-2018.The customer stated that the strips are properly stored and that the samples were tested appropriately.The customer stated that the strip tray has been cleaned, but the gray reference pad is not cleaned and appears to be dirty.The customer stated that they had not run any quality control solutions on the system.The customer did state that they did run calibration strips and calibration passed.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent to the customer.

Manufacturer Narrative

The customer did not return the meter or the test strips.Retention material of strip lot #21650700 was measured with native urine, an erythrocyte-dilution-series, a protein-dilution-series, and a leukocyte-dilution-series and was checked visually.The results of the measurements fulfill our requirements.No false negative results were observed.Further not substantiated complaints have been escalated for the same strip lot.The investigation was unable to determine a definitive root cause.The device was requested for return but was not provided.

• 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: 7425734
• MDR Text Key: 105892346
• Report Number: 1823260-2018-01143
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• 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?: No
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1