MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	03P68-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.
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.
Event or Problem Description
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.

• Brand Name: ARCHITECT MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24519781
• Report Number: 3002809144-2026-00054
• Device Sequence Number: 15883812
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: (01)00380740161637(17)260312(10)10599UN25
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2026
• Device Catalogue Number: 03P68-32
• Device Lot Number: 10599UN25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, (B)(6).; ARC C16K PRC MOD, 03L77-01, (B)(6).
• Patient Age: 3 DA
• Patient Sex: Female