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

Catalog Number 11895354160

Device Problems False Negative Result (1225); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

The meter and test strips were requested for investigation.The investigation is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 329487365
• Report Number: 1823260-2023-03817
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537180037
• UDI-Public: 00075537180037
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K896454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1