MAUDE Adverse Event Report: ACON LABORATORIES, INC. URISPEC 10SG URINE STRIPS; URINALYSIS REAGENT STRIPS

Lot Number URS1080121

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

The distributor reported that the uristicks are not showing the right colors.More information was later provided by the distributor that "the customer did use the test strips to test urine samples.Some of the results were negative and some results were symptomatic.When the discoloration appeared in multiple areas, they stopped using the product.

Manufacturer Narrative

In this follow-up report, the following information is different from the initial report as the internal investigation was completed.G6: type of report h2: if follow-up, what type? h3: device evaluated by manfuacturer h6: event problem and evaluation codes the final investigation yielded the following conclusion: batch records for final product manufacture and qc record for (b)(6)were reviewed and no abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The products were manufactured according to normal flow chart and had passed qc inspection.The test results of retained urine strips urs1080121 were normal.We have not found the complaint issue for the retained strips.The customer did not provide the pad information.

Event Description

The distributor reported that the uristicks are not showing the right colors.More information was later provided by the distributor that "the customer did use the test strips to test urine samples.Some of the results were negative and some results were symptomatic.When the discolaration appeared in multiple areas, they stopped using the product.

• Brand Name: URISPEC 10SG URINE STRIPS
• Type of Device: URINALYSIS REAGENT STRIPS
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego CA 92121
• Manufacturer (Section G): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego CA 92121
• Manufacturer Contact: qiyi xie ; 5850 oberlin drive, #340; san diego, CA 92121
• MDR Report Key: 17176443
• MDR Text Key: 317770911
• Report Number: 2531491-2023-00612
• Device Sequence Number: 1
• Product Code: CDM
• Combination Product (y/n): Y
• PMA/PMN Number: K061559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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
• Device Expiration Date: 10/22/2023
• Device Lot Number: URS1080121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1