MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 10 WITH SG URINE TEST STRIPS

Catalog Number	11895362160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer complained of false positive nitrite results for some patient urine samples from chemstrip 10 sg test strips.The issue did not occur with all patient urine samples.The customer did visual tests and noticed she was getting positive nitrite results.She expected the results to be negative as she did not see bacteria in the sediment of the urine samples with a microscope.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer stored the test strips correctly and the strip pad was white before use.The customer did not use urine samples that were red or pink.The qc was acceptable.The suspect product was requested to be returned for investigation.This medwatch will cover test strip lot 22262702.Refer to medwatch with patient identifier (b)(6) for information on test strip lot 21650803.
Additional Manufacturer Narrative
The customer provided test strip lot 22262702 for investigation.The customer material of lot 22262702 and the retention material of the lot 22262700 and lot 21650800 were visually checked with native urine and a nitrite-dilution series.The results of the measurements fulfill the requirements.No false positive results were observed.

• Brand Name: CHEMSTRIP 10 WITH SG URINE TEST STRIPS
• Common Device Name: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7818033
• Report Number: 1823260-2018-02862
• Device Sequence Number: 19444613
• Product Code: JIL
• UDI-Device Identifier: 00075537171455
• UDI-Public: 00075537171455
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K896454
• 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
• Report Date (Section B): 09/24/2018

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: 11/30/2018
• Device Catalogue Number: 11895362160
• Device Lot Number: 22262702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1