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	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained they were receiving false positive nitrite results for patient urine samples from urisys 1100 urine analyzer serial number (b)(4).The doctors requested that the customer start doing visual reads when the patient's nitrites tested positive on the meter.After a few meter and visual reads, the visual results were negative but the meter still produced positive results for nitrites.The nitrite results were negative with visual tests and believed to be correct.The customer repeated the testing multiple times and received the same results.The customer does not run qc.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 25566400 was measured on an urisys 1100 with native urine and a nitrite dilution series and was visually checked.The results of the measurements fulfill our requirements.No false positive results were observed.
Event or Problem Description
The retention material of lot #25566400 was measured on an iu urisys 1100 with 0-native urine and a nitrite-dilution-series and was visually checked.The results of the measurements fulfill our requirements.No false positive results were observed.
Additional Manufacturer Narrative
The lot number that was initially provided was incorrect.Medwatch field d4 was updated.
Additional Manufacturer Narrative
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: 8071265
• Report Number: 1823260-2018-04276
• Device Sequence Number: 2190036
• 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): 01/07/2019

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: 03260763160
• Device Lot Number: 25566401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018; 10/19/2018; 10/19/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 11/29/2018; 12/17/2018; 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1