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	09/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of false negative results for 1 patient urine sample from chemstrip 10 sg test strip on a urisys 1100 urine analyzer serial number (b)(4).The nitrite and leukocytes results from the meter were negative.The urine sample was sent to the laboratory for a culture.The laboratory culture was positive for escherichia col (e.Coli).There was no allegation of an adverse event.The patient's condition was "good".The customer was not using liquid qc.The suspect product was requested to be returned for investigation.
Additional Manufacturer Narrative
The retention material of lot 23841500 was measured on a urisys 1800 analyzer and was visually checked with native urine, a nitrite dilution series and a leukocytes dilution series.The results of the measurements fulfill requirements.No false negative results were observed.
Additional Manufacturer Narrative
The retention material of lot 23841500 was measured on a urisys 1800, cobas u411, a urisys 1100 analyzer, and the customer's urisys 1100 analyzer with native urine, a nitrite dilution series, and a leucocytes 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: 8008604
• Report Number: 1823260-2018-03863
• Device Sequence Number: 170053
• 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): 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: 10/31/2018
• Device Catalogue Number: 03260763160
• Device Lot Number: 23841503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 10/08/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/27/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CIPROFLOXACIN
• Patient Age: 46 YR