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

Catalog Number	03260763160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer complained of questionable protein, glucose, ketones, erythrocytes, and nitrite results for 1 patient urine sample tested with chemstrip 10 md urine test strips on a urisys 1000 urine analyzer serial number (b)(4).Of the data provided, there was a discrepant nitrite result compared to a laboratory analyzer.The nitrite result was positive on the urisys 1000 analyzer.The nitrite result was negative on the laboratory analyzer.The laboratory method was asked for but not provided.There were erroneous results reported outside of the laboratory.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.
Additional Manufacturer Narrative
The customer material was provided for investigation.Medwatch fields were updated.The retention material of lot 28811300 and the customer material of lot 28811303 were both measured on a urisys 1800, a cobas u411, a urisys 1100, and the customer's urisys 1100 with a native urine, a nitrite dilution series, erythrocytes dilution series, a glucose dilution series, a protein dilution series, and a specific gravity dilution series.The results of the measurements fulfill the requirements.No false positive results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The retention material of lot 28811300 was measured on a urisys 1800 with native urine, a nitrite dilution series, erythrocytes dilution series, a glucose dilution series, a protein dilution series and a specific gravity dilution series.The results of the measurements fulfill our requirements.No false positive results were observed.
Additional Manufacturer Narrative
The "urisys 1000 urine analyzer" in the initial mdr should have been "urisys 1100 urine analyzer".

• Brand Name: CHEMSTRIP ® 10 MD
• Common Device Name: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7842885
• Report Number: 1823260-2018-02972
• Device Sequence Number: 11154477
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 28811303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 08/15/2018; 08/15/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/24/2018; 11/06/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1