MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 10 MD; URINE TEST STRIPS

Catalog Number	03260763160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant negative results for 1 patient urine sample tested with the chemstrip 10 md urine test strips when compared to a microscopic urinanalysis testing.The leucocytes result from the urine test strip was visually read as negative while it resulted in a leucocytes value of >100 when it was tested microscopically.The unit of measurement was not provided.The customer stated that the physician sent out the samples for re-testing because symptoms were shown on the patient.
Additional Manufacturer Narrative
The expiration date of the test strip lot number 75515403 was 31-mar-2025.The customer stated that they do not perform any qc on the strips.The 2 test strips lot numbers were received for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Correction: one test strips lot number was received for investigation instead of two.Section d9 was updated.One vial of the customer's test strips' lot number 77738702 containing 45 of 100 test strips was received for investigation and showed no signs of damage and no abnormalities.The received test strips lot number 77738702 and the retention material lot numbers 75515400 and 77738700 were all measured by visual reading with 0-native-urine and a leucocytes-dilution-series.The investigation results revealed that no false negative results were observed and that the materials fulfill the requirements.The product release/stability review of the customer's test strips' lot numbers 77738702 and 75515403 passed all checks during production steps and were released without restrictions.The investigation did not identify a product problem.The root cause was consistent with the supernatant from the centrifuged sample been measured with the strips leading to a negative result when compared to laboratory result.Due to different measuring technology, the results may slightly differ and one range difference is acceptable.

• Brand Name: CHEMSTRIP 10 MD
• 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: 20438483
• Report Number: 1823260-2024-02971
• Device Sequence Number: 7990981
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032437
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 07/31/2025
• Device Catalogue Number: 03260763160
• Device Lot Number: 77738702, 75515403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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