CLINITEK STATUS+
Received Jun 11, 2024 · Event occurred Oct 11, 2023
Report 3002637618-2024-00067 · MDR key 19510243
Device
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE LEUKOCYTE RESULT ON A PATIENT SUSPECTED OF A URINARY TRACT INFECTION ON THEIR CLINITEK STATUS+ COMPARED TO RETESTING OF THE SAME SAMPLE ON A SEDIMENT ANALYZER. THE PERSON IN CHARGE OF THE TEST HAD DOUBTS ABOUT THE MEASUREMENT RESULTS AND CONDUCTED A RE-MEASUREMENT AND OBTAINED THE SAME RESULTS. THE RESULTS WERE REPORTED TO THE HOSPITAL DIRECTOR AND A URINE SEDIMENT SAMPLE WAS TAKEN AND WHITE BLOOD CELLS WERE OBSERVED. THE CUSTOMER DID NOTE THAT A COLOR REACTION ON THE TEST PAD INDICATING A POSITIVE RESULT WAS SEEN AFTER THE STRIP LEFT THE INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT THE PATIENT WAS TAKING SGLT2 INHIBITOR. SODIUM-GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITORS ARE A CLASS OF PRESCRIPTION DRUGS THAT ARE USED TO TREAT TYPE 2 DIABETES IN ADULTS. THEY WORK BY PREVENTING THE REABSORPTION OF GLUCOSE IN THE KIDNEY, WHICH INCREASES THE AMOUNT OF GLUCOSE THAT IS EXCRETED IN URINE. PER THE REAGENT IFU, ELEVATED GLUCOSE CONCENTRATIONS MAY CAUSE DECREASED LEUCOCYTE TEST RESULTS.