MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 10 WITH SG URINE TEST STRIPS

Catalog Number	11895362160
Medical Device Problem Codes	False Negative Result (1225); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strips were requested for investigation.
Event or Problem Description
The initial reporter complained of questionable negative results for an unspecified number of patients tested for leucocytes, blood and protein with chemstrip 10 with sg urine test strips.The results are being questioned as the patients were presenting with urinary tract infection (uti) symptoms, however, the test strip parameters were negative.The culture from the laboratory was returned as positive for these patients.
Additional Manufacturer Narrative
The test strips were not returned for investigation.The customer used a new vial of test strips and had no further issues.The retention material of lot 65249400 was measured by visual reading with a 0-native-urine, a leukocytes, a nitrite, an erythrocytes and a protein-dilution-series.The results of all measurements fulfill the requirements.No false negative results were observed.Lot 65249402 passed all checks during production steps and was released without restrictions.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP 10 WITH SG URINE TEST STRIPS
• Common Device Name: URINE TEST STRIPS
• 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: 17552034
• Report Number: 1823260-2023-02646
• Device Sequence Number: 17816289
• Product Code: JIL
• UDI-Device Identifier: 00075537171455
• UDI-Public: 00075537171455
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K896454
• 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): 09/21/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 11895362160
• Device Lot Number: 65249402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BABY ASPIRIN.; CALCIUM.; CARVEDILOL.; COLACE.; FUROSEMIDE.; MEGA RED KRILL OIL.; METFORMIN.; POTASSIUM.; ROSUVASTATIN.; WARFARIN.
• Patient Age: 69 YR
• Patient Sex: Female