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

Catalog Number	03260763160
Medical Device Problem Codes	False Negative Result (1225); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a false negative erythrocyte result using chemstrip 10 md and the urisys 1100 urine analyzer.The initial result was negative.The visual reading of repeat testing of the same sample gave a result of 50 ery/ul.The customer noted rbcs present on the microscopic exam of the sediment.
Additional Manufacturer Narrative
The urisys 1100 urine analyzer serial number was (b)(6).The test strips were requested to be returned for investigation.
Additional Manufacturer Narrative
Medwatch field d9 was updated one vial of chemstrip 10 md lot 71391905 and urisys 1100 analyzer serial number (b)(6) were received for investigation.The analyzer and test strip vial show no abnormalities and no signs of damage.The retention material of parent lot 71391900 and the customer material of lot 71391905 were measured on a retention urisys 1100 analyzer and on the customer urisysy 1100 analyzer with native-urine, an erythrocytes-dilution-series, a leukocytes-dilution-series, a nitrite-dilution-series, and a ketone-dilution-series.No false negative results were observed and all materials fulfilled the requirements.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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: 19350567
• Report Number: 1823260-2024-01501
• Device Sequence Number: 20683526
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 08/31/2024
• Device Catalogue Number: 03260763160
• Device Lot Number: 71391905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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