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

Catalog Number 03260763160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Event Description

The customer complained of false (b)(6) nitrite results for two patient urine samples from urisys 1100 urine analyzer serial number (b)(4).The nitrite results from the meter were (b)(6).The customer stated that one patient had a negative result with a visual test using a different test strip.It was not clear if a visual test was performed for the other patient.The patients were sent home after the (b)(6) nitrite results.Later in the day, both patients went to the emergency room because they were not feeling well.The customer stated that one patient was treated for a urinary tract infection.It was uncertain what the second patient was treated for and what the treatment was.There was no additional information about the treatment provided for either patient or the current status of the patients.This information was requested.The suspect device was requested to be returned for investigation.

Manufacturer Narrative

During internal testing, roche determined the limits of detection (lod) for protein, nitrite, leukocytes, and erythrocytes on the urisys 1100 urine analyzer with chemstrip® 5 ob, chemstrip 7, chemstrip 10 md, and chemstrip 10 ua test strips were higher than what is listed in their respective test strip method sheets.This can lead to false negative results on the urysis 1100 urine analyzer for the four affected parameters.Roche has provided customers with the following instructions and workarounds: chemstrip 5 ob and chemstrip 7 test strips should only be read visually.They can no longer be read on the urisys 1100 urine analyzer.Chemstrip 10 md or chemstrip 10 ua test strips can be used with the urisys 1100 urine analyzer; however, a negative result for any one of the four affected parameters (i.E., protein, nitrite, leukocytes, and erythrocytes) on the urisys 1100 urine analyzer must be repeated with a new test strip that is read visually.

Manufacturer Narrative

The retention material of lot 29191100 was measured on a urisys 1800 analyzer with native urine and a nitrite dilution series.The results of the measurements fulfill our requirements.No false negative results were observed.

Manufacturer Narrative

The retention material of lot 29191100 was measured on a cobas u411 analyzer with native urine and a nitrite dilution series.The results of the measurements fulfill our requirements.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
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8050429
• MDR Text Key: 128409302
• Report Number: 1823260-2018-04126
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 29191103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-09/12/18-006-C
• Patient Sequence Number: 1