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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned a result for 1 patient tested for leukocytes on a urisys 1100 urine analyzer.The reporter alleged the analyzer began to countdown at 45 seconds instead of 60 seconds.The analyzer result from a 45-second countdown was "normal." the customer repeated the test with a visual check due to the 45-second countdown on the meter instead of a 60-second countdown.The result from the visual check at 60 seconds was 2+ (positive).The positive visual result was believed to be correct.The urisys 1100 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
The meter and test strips were requested for investigation.The investigation stated the reason the analyzer counted down from 45 seconds instead of 60 seconds was that the countdown includes the total time from when the test strip is removed from the vial.After dipping, blotting, and inserting the test strip, approximately 15 seconds elapsed and then the 45-second countdown begins when the start button is pressed.Product labeling states: "it is important that the strip is correctly positioned and ready to be read within 5-10 seconds of dipping strip." the investigation is ongoing.
Additional Manufacturer Narrative
The meter and test strips were received for investigation.Sections d9 and h3 were updated.The test strips showed no signs of discoloration.The meter was dirty on the outside.The strip tray was severely contaminated due to dirt under the clip causing a gap, therefore, the test strip can't be pushed sufficiently into the tray.The retention material of lot 64620500 and the customer's material of lot 64620501 was checked by visual reading with 0-native-urine and a leucocytes dilution.The retention material of lot 64620500 and the customer material of lot 64620501 was measured on a urisys 1100 at the investigation site and the customer's urisys 1100 with 0-native-urine and a leucocytes dilution.The results of all measurements fulfill the requirements.No abnormal results were observed.The contaminated strip tray can cause the test strip to be positioned incorrectly and lead to incorrect results.Product labeling states the meter and test strip tray should be cleaned daily: "moisten a cloth with water, wring it out (the cloth must be damp not soaked) and clean the exterior parts and surfaces of the instrument." and cautions "ensure that no liquid enters the instrument, wipe the housing, and never spray it! let the housing dry before proceeding to read." and "pull the test strip tray out of the instrument.Rinse the test strip tray under running water." and cautions "ensure that the positioning hole on the side of the test strip tray is absolutely dry.This hole is used to ensure that the test strip tray is automatically positioned correctly in the instrument." the test strip must be pushed completely under the clip without a gap to ensure reproducible results.The investigation did not identify a product problem.

• Brand Name: CHEMSTRIP 10 MD
• Common Device Name: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16404058
• Report Number: 1823260-2023-00512
• Device Sequence Number: 3365011
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 11/30/2023
• Device Catalogue Number: 03260763160
• Device Lot Number: 64620501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: UNSPECIFIED HIGH BLOOD PRESSURE MEDICATION
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 84 KG