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

Catalog Number	03260763160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of false negative nitrite and erythrocytes results for patient urine samples from urisys 1100 urine analyzer serial number (b)(4).The nitrite result from the meter was negative and the result was positive with the visual test.The erythrocytes result from the meter was negative and the result was positive with the visual test.The specific date of the measurements was not provided.There was no allegation of an adverse event.The qc was acceptable.The suspect product was requested to be returned for investigation.The retention material of lot 27638300 was measured on a urisys 1800 analyzer and was visually checked with native urine and a nitrite dilution series.The results of the measurements fulfill our requirements.No false negative results were observed.
Additional Manufacturer Narrative
The customer's meter and test strips were provided for investigation.The meter was returned without a test strip tray.The meter was clean and no damage.The returned test strips had no discolorations or abnormalities.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.
Additional Manufacturer Narrative
The retention material of lot 27638300 was measured on a cobas u411 and was visually checked 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
• Common Device Name: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8059677
• Report Number: 1823260-2018-04180
• Device Sequence Number: 1459396
• 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
• Report Date (Section B): 08/23/2019

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: 01/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 27638305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 10/23/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/28/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1823260-09/12/18-006-C
• Patient Sequence Number: 1