ALINITY C MAGNESIUM
Received Apr 20, 2026 · Event occurred Feb 19, 2026
Report 3005094123-2026-00187 · MDR key 24927425
Device
Generic name
Photometric Method, Magnesium
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
08P19-25
Lot number
77635UD00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY C MAGNESIUM LOT 77635UD00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. AS PART OF TROUBLESHOOTING THE CUSTOMER RERUN THE SAMPLES AND OBTAINED ACCEPTABLE RESULTS. THE QUALITY CONTROL RESULTS WERE ALSO ACCEPTABLE AT THE TIME OF TESTING. THE CUSTOMER THINKS THIS IS DUE TO REAGENT BUBBLES. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY C MAGNESIUM LOT 77635UD00. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT ON (B)(6) 2026 AT 1720 >9.5 MG/DL (REPORTED OUT OF THE LAB), REPEATED 1.92 MG/DL (NORMAL RANGE 1.4 TO 2.4 MG/DL). A NEW SAMPLE WAS OBTAINED SID (B)(6) RESULTED (B)(6) 2026 AT 1853 RESULT 1.91 MG/DL. NO SID PROVIDED, INITIAL RESULT >9.5 MG/DL, REPEATED 1.67 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.