ALINITY C PHOSPHORUS
Received Jul 22, 2019 · Event occurred Jul 2, 2019
Report 3002809144-2019-00462 · MDR key 8813291
Device
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE LOT NUMBER 86490UN18 WAS ADDED IN SECTION D OF THIS REPORT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR FALSELY ELEVATED PATIENT RESULTS AND NO TRENDS WERE IDENTIFIED FOR THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PHOSPHORUS ASSAY WAS IDENTIFIED.
Additional Manufacturer Narrative
PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C PHOSPHORUS RESULT FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = MMOL/L, REFERENCE RANGE = 0.74-1.52 MMOL/L): INITIAL RESULT = 3.22, REPEAT = 1.23. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.