ARCHITECT MAGNESIUM
Received Mar 5, 2026 · Event occurred Feb 25, 2026
Report 3002809144-2026-00054 · MDR key 24519781
Device
Generic name
Photometric Method, Magnesium
Manufacturer
Abbott GmbhCatalog number
03P68-32
Lot number
10599UN25
Product problems
- High Test Results
Patient
3 DA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT MAGNESIUM, LIST 03P68-32, ABBOTT GMBH, WIESBADEN, GERMANY TO THE ARCHITECT C16000 PROCESSING MODULE, LIST 03L77-01, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2026-00138-00 HAS BEEN SUBMITTED, AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE 3 DAY OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL TEST 2.60 MMOL/L, RETEST 0.98 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: INITIAL TEST 2.60 MMOL/L, RETEST 0.98 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.