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

Catalog Number	03260763160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of false positive nitrite results for over 40 patient urine samples on a urisys 1100 analyzer serial number (b)(4) since (b)(6) 2018.The specific results were asked for but not provided.There were erroneous results reported outside of the laboratory.There was no allegation of an adverse event.No treatment or actions were taken based on the results.The customer stated that they dipped a test strip in water and the nitrite result was a falsely positive.The customer stated that the nitrites portion of a test strip that had not been used appeared "pinkish".The customer stated that the calibration was acceptable.The suspect product was requested to be returned for investigation.The retention material of lot 27638300 was measured on an iu urisys 1800 with native urine and a nitrite dilution series.The results fulfilled the requirements.No false positive results were observed.
Additional Manufacturer Narrative
Medwatch fields device available for evaluation? and device evaluated by mfr? were updated.A vial of test strips was returned for investigation.The investigation determined that the nitrite test pads of all the returned test strips were discolored.There were no discolored test pads in the retention material.The error was consistent with mishandling.In relation to strip handling the package insert states "in order to avoid exposure to moisture, the vial must be closed immediately after removal of a strip, using the original stopper, which contains a drying agent.".

• 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: 7809501
• Report Number: 1823260-2018-02838
• Device Sequence Number: 19118478
• 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): 10/18/2018

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: 01/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 27638305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1