MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 MD; URINE TEST STRIPS

Catalog Number 03260763160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

The customer complained of questionable leukocytes, nitrite, protein, glucose, and urobilinogen results for 1 patient urine sample tested with chemstrip 10 md urine test strips on a chemstrip 101 urine analyzer serial number (b)(4).Of the data provided, there were discrepant nitrite results.The initial nitrite result was positive.The repeat nitrite result was negative.There was no allegation of an adverse event.The calibration and qc were acceptable.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

The customer material was returned for investigation.The retention material of lot 32223100 and the customer material of lot 32223101 were both checked on a cobas urisys 1800 / cobas u411 with native urine, a nitrite dilution series, a protein dilution series, a glucose dilution series, and a leucocytes dilution series.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8195664
• MDR Text Key: 131832776
• Report Number: 1823260-2018-05103
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 32223101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR