MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 411 URINE ANALYZER; AUTOMATED URINALYSIS SYSTEM

Catalog Number 04906969001

Device Problem Non Reproducible Results (4029)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

The test strip lot number and expiration date were requested, but not provided.The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for an unspecified number of patient samples tested on a cobas u 411 urine analyzer.Multiple test parameters are affected.The customer provided an example of one patient sample with discrepant leukocyte values.The sample initially resulted in a leukocyte value of 500 leukocytes/ul.The same sample was repeated, resulting in a negative leukocyte value.

Manufacturer Narrative

The quality controls failed.The field service engineer replaced the photometer and the instrument was working properly after this action.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS U 411 URINE ANALYZER
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• 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: 18725239
• MDR Text Key: 335611680
• Report Number: 1823260-2024-00467
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K093555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04906969001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1