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

Catalog Number	03260763160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of (b)(6) results for patient urine samples tested with chemstrip 10 md urine test strips on a urisys 1100 urine analyzer serial number (b)(4).The leukocytes, nitrite, and erythrocytes results were (b)(6) on the urisys 1100.The results were (b)(6) with a visual inspection and the laboratory culture was (b)(6).The specific results were 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 retention material of lot 28811300 was measured on a urisys 1800 analyzer with native urine, a nitrite dilution series, a leukocytes dilution series and an erythrocytes dilution series.No false negative results were observed.
Additional Manufacturer Narrative
The customer's test strips were provided for investigation.The customer material of lot 28811303 and the retention material of lot 28811300 were both measured on a urisys 1800 analyzer with native urine, a nitrite dilution series, a leucocytes dilution series and a erythrocytes dilution-series.No false negative results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8013579
• Report Number: 1823260-2018-03882
• Device Sequence Number: 1434869
• 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
• 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: 10/12/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018; 10/09/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/27/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1