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

Model Number	U1100
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was requested to be returned for investigation.The alleged sample was fresh urine at room temperature.The investigation reviewed retention material and no abnormalities were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter received discrepant results for 1 patient with chemstrip 10 md urine test strips on a urisys 1100 analyzer.A visual reading of the chemstrip indicated the leukocyte, glucose, blood, and protein results were negative/normal.The urisys 1100 analyzer results indicated the results were positive.The leukocyte result was 500.The glucose result was 250.The blood result was 50.The protein result was positive, but an exact result was not provided.The units of measure were not provided.The patient was not treated based on the results.The negative results were believed to be correct.The chemstrip lot number is 58170605 with an expiration date of 30-apr-2023.
Additional Manufacturer Narrative
The customer's analyzer was visually checked and showed a massively polluted test strip tray and analyzer housing.Retention material test strips of combur 10 ux lot 58170600, were placed on the customer's returned tray to check the correct test strip position.The retention material of lot 58170600 was measured on an iu (investigation unit) urisys 1100 analyzer and the customer's urisys 1100 analyzer s/n (b)(6).The customer's analyzer was also used for a measurement series with the installed iu tray.The iu analyzer was also used for a measurement series with the installed customer tray.The customer's analyzer was opened for investigation.All measurements were carried out with 0-native urine.The customer's analyzer tray was massively polluted, so the test strips cannot be placed in the correct position.The investigation results show a remission value difference between the iu analyzer and the test strip analyzer.The customer's analyzer with an installed iu tray shows normal results.Erythrocytes results showed a total of 10 % false positive results with customer equipment (analyzer & tray).For urobilinogen and erythrocytes results, the customer's equipment showed significantly darker remission values, which leads to partly borderline results to positive ranges.The test strip cannot be correctly positioned onto the customer tray, due to the pollution and can cause discrepant results.The investigation found the customer's test strip tray was massively polluted, which caused the alleged issue.The investigation determined the issue was caused by customer mishandling.

• Brand Name: URISYS 1100
• Common Device Name: AUTOMATED URINE ANALYZER
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15302885
• Report Number: 1823260-2022-02585
• Device Sequence Number: 20177089
• Product Code: KQO
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033548
• 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): 10/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: U1100
• Device Catalogue Number: 03617556001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown