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

Catalog Number 11895362160

Device Problems False Negative Result (1225); Device Difficult to Setup or Prepare (1487)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 321584501
• Report Number: 1823260-2023-02646
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537171455
• UDI-Public: 00075537171455
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K896454
• 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,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/15/2023
• 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
• Treatment: BABY ASPIRIN.; CALCIUM.; CARVEDILOL.; COLACE.; FUROSEMIDE.; MEGA RED KRILL OIL.; METFORMIN.; POTASSIUM.; ROSUVASTATIN.; WARFARIN.
• Patient Age: 69 YR
• Patient Sex: Female