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	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer complained of questionable nitrite results for 1 patient urine sample on two urisys 1100 analyzers.The result was positive on urisys 1100 serial number (b)(4).The result was negative on urisys 1100 serial number (b)(4).The erroneous result was reported outside of the laboratory.The doctor felt the negative result was correct based on the patient symptoms.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.
Additional Manufacturer Narrative
The customer provided material for investigation.The retention material of lot 29191000 and the customer material of lot 29191001 were measured on an iu urisys 1800 and a cobas u411 analyzer with native urine and a nitrite dilution series.The results of the measurements fulfill our requirements.No abnormal results, neither false negative nor false positive 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: 7933473
• Report Number: 1823260-2018-03416
• Device Sequence Number: 930776
• 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): 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: 03/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 29191001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1