MEDLINE URINALYSIS REAGENT STRIPS

Description of Event or Problem

ON (B)(6) 2025 THE CUSTOMER NOTIFIED MEDLINE STATING THE SOLUTION IN THE KIT TESTING FOR SPECIFIC GRAVITY YIELDED A POSITIVE RESULT WHEN COMPLETING QA VERIFICATION TESTING. THEY ALSO REPORTED AN INSTANCE OF A URINE STRIP TEST THAT YIELDED A FALSE NEGATIVE RESULT THAT WAS TESTING FOR SPECIFIC GRAVITY CONCENTRATION ON THE PATIENT. THE FALSE NEGATIVE LEAD TO AN MDR EVENT AND CAUSED THE CLIENT TO HAVE SEVERE UTI SYMPTOMS.

Description of Event or Problem

ON (B)(6) 2025 THE CUSTOMER NOTIFIED MEDLINE STATING THE SOLUTION IN THE KIT TESTING FOR SPECIFIC GRAVITY YIELDED A POSITIVE RESULT WHEN COMPLETING QA VERIFICATION TESTING. THEY ALSO REPORTED AN INSTANCE OF A URINE STRIP TEST THAT YIELDED A FALSE NEGATIVE RESULT THAT WAS TESTING FOR SPECIFIC GRAVITY CONCENTRATION ON THE PATIENT. THE FALSE NEGATIVE LEAD TO AN MDR EVENT AND CAUSED THE CLIENT TO HAVE SEVERE UTI SYMPTOMS.

Additional Manufacturer Narrative

IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION IS DIFFERENT THAN THE INITIAL REPORT. B4: DATE OF THIS REPORT. G6: TYPE OF REPORT. H2: IF FOLLOW-UP, WHAT TYPE? H6: ADVERSE EVENT PROBLEM. THE FINAL INVESTIGATION YIELDED THE FOLLOWING CONCLUSION: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR 98124030001 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 TEST RESULTS OF RETENTION SAMPLES FROM 98124030001 MET THE QC CRITERIA. IN HOUSE TESTING WAS PERFORMED WITH RETAINED STRIPS, NEGATIVE AND POSITIVE CONTROLS, SIEMENS MULTISTIX 10SG AND 20 CLINICAL SAMPLES. THE SPECIFIC GRAVITY PAD SHOWS CORRECT PERFORMANCE WHEN TESTED WITH URINE CONTROLS AND CLINICAL URINE SAMPLES. WE HAVE NOT FOUND THE COMPLAINT ISSUE WHEN COMPARING WITH SIEMENS MULTISTIX 10SG STRIPS, THE SG PAD SHOWS THE SAME AND CORRECT VALUE WHEN TEST BY VISUAL AND BY ANALYZER. THE ROOT CAUSE COULD NOT BE DETERMINED.