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	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of a false negative erythrocyte result for 1 patient urine sample that was tested on a urisys 1100 urine analyzer with serial number (b)(4) and compared to an unknown laboratory method.The initial erythrocyte result from the urisys was negative.The sample was sent to another hospital and a result of 3 or 4 plus.The customer could not remember the exact time between the measurements but did state that they were done between 6-24 hours of each other.The erroneous result was released outside of the laboratory.There was no allegation of an adverse event.Qc testing was performed with acceptable results.The meter and test strips have been requested for investigation.The retention material of the lot 32223100 was measured on an iu u 1800 analyzer with 0-native urine, and an erythrocytes-dilution-series.No false negative results were observed.The investigation is currently ongoing.
Additional Manufacturer Narrative
The customer's meter was returned.The test strip tray was inserted too deep into the analyzer.During self-check, an error message "e10 light barrier error" was produced.As the tray did not move out of the analyzer, no measurements could be made on the customer's analyzer.The test strips were not returned.
Additional Manufacturer Narrative
No further investigation is possible since the customer did not return the requested product for testing.

• 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: 8060594
• Report Number: 1823260-2018-04199
• Device Sequence Number: 11483005
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2019

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: 07/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 32223101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 10/24/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/25/2019; 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1