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

Catalog Number	03P68-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
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.
Event or Problem Description
The customer observed a falsely elevated magnesium result generated on an architect c4000 analyzer for one patient.The initial result = 7.56 mg/dl, repeat result = 1.83 mg/dl (reference range 1.6-2.6 mg/dl).There was no impact to patient management.
Additional Manufacturer Narrative
Additional information provided in section a1 patient sample id: (b)(6), b5 sample id added to incident description, d4 lot number, expiration date, and primary udi.After further evaluation, the suspect medical device was changed from magnesium, list number 03p68-22, abbott gmbh, max-planck-ring 2, wiesbaden, deu 65205 to architect c4000, list number 02p24-40, abbott laboratories, 1915 hurd drive, irving, tx 75038.Mdr number 3016438761-2024-00557-00 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 an architect c4000 analyzer for one patient.The initial result = 7.56 mg/dl, repeat result = 1.83 mg/dl (reference range 1.6-2.6 mg/dl).There was no impact to patient management.Update: patient sample id: (b)(6).

• Brand Name: 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: 20063115
• Report Number: 3002809144-2024-00250
• Device Sequence Number: 18074641
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: (01)00380740161620(17)250104(10)62468UD00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 01/04/2025
• Device Catalogue Number: 03P68-22
• Device Lot Number: 62468UD00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/23/2024
• 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 C4000 INTGR, 02P24-40, (B)(6). ; ARC C4000 INTGR, 02P24-40, (B)(6).
• Patient Sex: Unknown