ARCHITECT Magnesium
Received Jun 30, 2026 · Event occurred May 15, 2026
Report 3005094123-2026-00321 · MDR key 25665322
Device
Generic name
Photometric Method, Magnesium
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
03P68-24
Lot number
83306UD00
Product problems
- High Test Results
Patient
29 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 FALSELY ELEVATED MAGNESIUM RESULTS GENERATED BY THE ARCHITECT C4000 PROCESSING MODULE FOR A PATIENT. THE RESULTS WERE NOT RELEASED. THE SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WERE PROVIDED: NORMAL RANGE: 1.6 TO 2.6 MG/DL (B)(6) 2026 SID (B)(6). INITIAL RESULT = 9.14 MG/DL REPEAT RESULT ON THE SAME INSTRUMENT = 3.96 MG/DL REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 1.9 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.