URISPEC 10SG URINE STRIPS
Received Jun 21, 2023 · Event occurred Jun 16, 2023
Report 2531491-2023-00612 · MDR key 17176443
Device
Product problems
- Material Discolored
- Material Discolored
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional 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.
Description of Event or Problem
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.
Description of Event or Problem
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.