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

Catalog Number	03260763160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of false negative nitrite and leukocytes results for some patient urine samples from chemstrip 10 sg test strips on a urysis 1100 serial number (b)(4).The customer provided examples.The patient had symptoms of a urinary tract infection but the nitrite and leukocytes results were negative.The sample was sent to the laboratory.The nitrite and leukocytes results were positive in the laboratory.The customer stated that in other cases the nitrite and leukocytes results were positive for a test strip and negative for a different test strip.The customer did not believe the first results were correct.The customer suspected contamination and cleaned the instrument.There was no allegation of an adverse event.The calibration was acceptable.The customer was not using qc.The suspect product was requested to be returned for investigation.The retention material of lot 29191100 was measured on an urisys 1800 analyzer with native urine and a nitrite dilution series and a leucocyte 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 returned for investigation.The retention material of lot 29191100 and the customer material of lot 29191103 were both measured on an urisys 1800, a cobas u411 analyzer, a urisys 1100 analyzer, and the customer's urisys 1100 analyzer with native urine, a nitrite dilution series and a leucocyte 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: 7984424
• Report Number: 1823260-2018-03759
• Device Sequence Number: 1747010
• 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
• Report Date (Section B): 12/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 29191103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1