PICCOLO COMPREHENSIVE METABOLIC PANEL
Received Jul 30, 2020 · Event occurred Sep 12, 2019
Report 2939693-2020-00080 · MDR key 10347603
Device
Product problems
- High Readings
- High Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ON 12-SEP-2020, ABAXIS WAS CONTACTED BY THE CUSTOMER LAB STATING THAT A LAB RESULT YIELDED AN UNEXPECTED HIGH CHLORIDE RESULT WHEN COMPARED TO SODIUM RESULTS. THE RECOMMENDED REFERENCE RANGE FOR THE PICCOLO SYSTEM IS 98-108MMOL/L. THE CUSTOMER SENT THE DATA FOR ABAXIS FOR REVIEW. THE LAB RAN CONTROLS ON 10-SEP-2020 AND BOTH LEVELS WERE IN RANGE, INDICATING THAT THE PICCOLO SYSTEM WAS PERFORMING AS EXPECTED. A REVIEW OF THE BATCH RECORD SHOWED THAT THE LOT WAS REVIEWED DUE TO A SHIFT IN SODIUM VALUES AND WAS SPLIT INTO TWO LOTS. BOTH SUB-LOTS MET ALL RELEASE CRITERIA. ROTORS FROM THIS LOT WERE INVESTIGATED FROM ANOTHER CALL (M924310) AND THE HIGH CHLORIDE ISSUE COULD NOT BE DUPLICATED. THE HIGH OF 107MMOL/L IS THE LAB'S SET HIGH END OF THE RANGE. THE RESULT OF 108MMOL/L FALLS WITHIN THE RECOMMENDED PICCOLO REFERENCE RANGE. A REVIEW OF THE COMPLAINT DATA SHOWED THAT THERE WERE A TOTAL OF 40 ROTORS FROM THIS LOT WITH ALLEGED HIGH CHLORIDE RESULTS OUT (B)(4) ROTORS SHIPPED FOR A COMPLAINT RATE OF 0.37%. THE CUSTOMER LAB HAS NOT EXPERIENCED ANY NEW HIGH CHLORIDE RESULTS THAT WERE NOT EXPECTED. THERE WAS NO REPORTED PATIENT IMPACT AND NO OBSERVED TREND. THE PICCOLO DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER ACTIONS WERE REQUIRED. THIS MDR IS BEING SUBMITTED AS A RESULT OF A THREE (3) YEAR RETROSPECTIVE REVIEW OF CLOSED COMPLAINTS ABAXIS PERFORMED AS PART OF ITS COMMITMENT TO CORRECT THE FDA-483 OBSERVATIONS RECEIVED ON AUGUST 22, 2019.
Description of Event or Problem
THE CUSTOMER LAB REPORTED THAT THE DEVICE YIELDED AN UNEXPECTED HIGH CHLORIDE RESULT WHEN COMPARED TO SODIUM RESULTS.