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

Catalog Number 03260763160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Event 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.

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 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.

Manufacturer Narrative

The lot number that was initially provided was incorrect.Medwatch field d4 was updated.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8071265
• MDR Text Key: 129166890
• Report Number: 1823260-2018-04276
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 03260763160
• Device Lot Number: 25566401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 10/19/2018; 10/19/2018
• Supplement Dates FDA Received: 11/29/2018; 12/17/2018; 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1