MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 701 MICROSCOPY ANALYZER; AUTOMATED URINALYSIS SYSTEM

Model Number U701

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the issue was consistent with poor sample quality.The quality of the sample caused the analyzer to not detect any cells due to blurriness and mucus.The investigation could not identify a product problem.

Event Description

The initial reporter stated they received false negative results for one patient sample tested for bacteria and leukocytes on a cobas u 701 microscopy analyzer.The leukocyte and bacteria results measured from the sample were negative.The sample was found to be completely full of leukocytes and bacteria.The pictures from the u 701 analyzer were noted to be very fuzzy.

• Brand Name: COBAS U 701 MICROSCOPY 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13713724
• MDR Text Key: 293077655
• Report Number: 1823260-2022-00636
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: ASKU
• 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
• Report Date: 03/09/2022

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
• Device Operator: Health Professional
• Device Model Number: U701
• Device Catalogue Number: 06390501001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1