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

Catalog Number 11895362160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

Na.

Event 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.

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
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7818033
• MDR Text Key: 118555969
• Report Number: 1823260-2018-02862
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537171455
• UDI-Public: 00075537171455
• Combination Product (y/n): N
• PMA/PMN Number: K896454
• 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: 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
• Device Operator: 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 Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1