MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Catalog Number 03617556001

Device Problem No Device Output (1435)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The chemstrip urine test strips lot number is 70482004 with an expiration date of 31-jul-2024.The urine analyzer was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter complained that they received multiple questionable test results from an unspecified number of urine patient samples tested on the urisys 1100 urine analyzer.The reporter stated that they would receive multiple high results for all parameters from the analyzer, and when compared with the urine chemistry test strip results, the results did not match and the analyzer results were incorrect.The reporter stated that it would occur randomly and might be "two in a row" and then the results would be "okay" for a few tests.No questionable result was reported outside of the laboratory as they would question the results when multiple positives occurred and they would run the patient sample until they got a result that matched the visual reading; they would also receive an error "e2 wrong strip".The reporter was not able to provide specific examples of parameters with questionable results.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• 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: 18854832
• MDR Text Key: 337076287
• Report Number: 1823260-2024-00687
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033548
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03617556001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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