MEDLINE URINALYSIS REAGENT STRIPS
Received Jun 5, 2025 · Event occurred Mar 27, 2025
Report 2531491-2025-00122 · MDR key 22153205
Device
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ON (B)(6) 2025 THE CUSTOMER NOTIFIED MEDLINE SHARING THAT A URINE SAMPLE WAS TESTED WITH AN EXTERNAL METHOD AND BLOOD WAS FOUND TO BE IN THE URINE, BUT THE BLOOD WAS NOT DETECTED WITH THE MANUAL URINE TEST STRIP.
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 BLOOD 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 BLOOD PAD SHOWS THE SAME AND CORRECT VALUE WHEN TEST BY VISUAL AND BY ANALYZER THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
ON (B)(6) 2025 THE CUSTOMER NOTIFIED MEDLINE SHARING THAT A URINE SAMPLE WAS TESTED WITH AN EXTERNAL METHOD AND BLOOD WAS FOUND TO BE IN THE URINE, BUT THE BLOOD WAS NOT DETECTED WITH THE MANUAL URINE TEST STRIP.