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	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer complained of false negative erythrocytes and leukocytes results for 2 patient urine samples tested with chemstrip 10 md urine test strips on a urisys 1000 urine analyzer serial number (b)(4).The erythrocytes results were negative on the urisys 1000 analyzer.Approximately 60 to 120 seconds later on a different urisys 1000 analyzer and with a visual evaluation, the erythrocytes results were >50 ery/ul (positive).The leukocytes results were negative on the urisys 1000 analyzer.On a different urisys 1000 analyzer and with a visual evaluation, the leukocytes results were positive 60 seconds later.There were erroneous results reported outside of the laboratory.There was no allegation of an adverse event.The patients did not receive treatment based on the results.The customer was aware of an issue due to the false negative results.The calibration was successful.The suspect product was requested to be returned for investigation.
Additional Manufacturer Narrative
"urisys 1000 urine analyzer" in the initial mdr should have been "urisys 1100 urine analyzer".The retention material of lot 27638306 was measured on an urisys 1800 analyzer with native urine a leukocytes dilution series and an erythrocytes dilution series.No false negative results were observed.
Additional Manufacturer Narrative
The customer provided the urisys 1100 urine analyzer and test strips for investigation.The customer's analyzer could not be investigated.The test strip tray was inserted too deep and could not be removed.The analyzer would not start when connected to the power supply.The customer material of lot 27638305 was measured on a urisys 1800 analyzer with native urine a leukocytes dilution series and an erythrocytes dilution series.No false negative results were observed.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The test strip tray that had been inserted too deep was investigated on the returned urisys 1100 urine analyzer.The investigation determined that a seal was missing which indicated that the analyzer was disassembled and incorrectly reassembled.The analyzer was correctly reassembled and the analyzer check was acceptable.

• 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: 7842629
• Report Number: 1823260-2018-02967
• Device Sequence Number: 1445476
• 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,Followup,Followup
• Report Date (Section B): 01/28/2019

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: 27638306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 08/15/2018; 08/15/2018; 08/15/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/24/2018; 11/26/2018; 01/07/2019; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1