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

Catalog Number	03260763160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer received questionable low leukocyte and false negative nitrite results for quality control material and patient samples from urisys 1100 urine analyzer serial number (b)(4).Of the data provided, only the nitrite results were discrepant.Around 8 am, the patient urine sample was tested on the urisys 1100 and the result was negative for nitrite.The customer performed a microscopic exam of the sample under a 40x magnification and found bacteria was present.The sample was then cultured and showed greater than 100000 col/ml.The erroneous result was reported outside of the laboratory.The customer did not know the diagnosis provided to the patient and did not know what treatment the patient received.There was no allegation of an adverse event.The suspect urisys 1100 and strips were requested to be returned for investigation.Replacement product was sent.
Additional Manufacturer Narrative
The customer material of lot 27638305 and the retention material of lot 27638300 were both measured and no false negative results were observed.The investigation is ongoing.
Additional Manufacturer Narrative
Retention testing was performed using lot 27638300.No false negative results were observed.All results were within specifications.The customer provided test strips for investigation.No false negative results were observed.All results were within specifications.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: 7970331
• Report Number: 1823260-2018-03690
• Device Sequence Number: 18882482
• 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): 01/24/2019

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?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018; 09/27/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/04/2019; 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1