PICCOLO COMPREHENSIVE METABOLIC PANEL
Received Jul 30, 2020 · Event occurred Sep 26, 2019
Report 2939693-2020-00081 · MDR key 10347828
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 (B)(6) 2019, ABAXIS RECEIVED A CALL FROM THE CUSTOMER LAB STATING THAT THE DEVICE YIELDED MULTIPLE UNEXPECTED HIGH CHLORIDE RESULTS ON MULTIPLE PATIENTS. THE RECOMMENDED REFERENCE RANGE FOR THE PICCOLO SYSTEM IS 98-108MMOL/L. THE LAB RAN CONTROLS ON THE LOT ON (B)(6) 2019 AND BOTH LEVELS WERE IN RANGE. A REVIEW OF THE BATCH RECORD SHOWED THAT THE LOT MET ALL RELEASE CRITERIA. THE LAB RETURNED THEIR ANALYZER FOR REPAIR. IT WAS OBSERVED THAT OCCASIONAL TEMPERATURE SPIKES ABOVE 38 DEGREES CELSIUS WERE OCCURRING. THE HEATER PLATES WERE REPLACE TO RESOLVE THE REPORTED PROBLEM. THE TEMPERATURE WAS RECALIBRATED AND THE DEVICE WAS THOROUGHLY CLEANED. THE DEVICE WAS SENT BACK TO THE CUSTOMER SITE WHERE IT REMAINS. NO FURTHER ACTIONS WERE REQUIRED. THIS CALL WAS ORIGINALLY ONE ISSUE THAT WAS SPLIT DUE TO MULTIPLE PANEL LOTS (9215AB7, 9272AB1 9242AB1). THIS MDR ADDRESSES 9215AB7. 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 MULTIPLE UNEXPECTED HIGH CHLORIDE RESULTS ON MULTIPLE PATIENTS.