MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 UA; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number	11895354160
Medical Device Problem Codes	False Negative Result (1225); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter and test strips were requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable leukocyte results for four urine patient samples tested on the urisys 1100 urine analyzer us with serial number (b)(6).The reporter stated that the meter results were not aligned with the patients' symptoms prompting them to send the urine samples to the laboratory.Results for the four urine patient samples: the meter results were negative for leucocytes.The laboratory results were positive.The actual laboratory results were requested but not provided.The patients were treated based on the laboratory results.
Additional Manufacturer Narrative
The meter and test strips were not received for investigation.The retention material of the lot was tested; no false negative results were obtained.The retention material of the lot fulfilled the requirements.The investigation did not identify a product problem.

• Brand Name: CHEMSTRIP ® 10 UA
• Common Device Name: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18246712
• Report Number: 1823260-2023-03817
• Device Sequence Number: 6582041
• Product Code: JIL
• UDI-Device Identifier: 00075537180037
• UDI-Public: 00075537180037
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K896454
• 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): 01/11/2024

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: 11895354160
• Device Lot Number: 64616809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown