MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	03P68-24
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated magnesium result generated on the architect c4000 processing module for one sample.The following data was provided (customer provided reference range: 1.6 to 2.6 mg/dl): 04jul2023 sid078500166a initial result = 6.5 mg/dl, repeat = 1.93 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: (b)(4) 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 the architect c4000 processing module for one sample.The following data was provided (customer provided reference range: 1.6 to 2.6 mg/dl): 04jul2023 (b)(6) initial result = 6.5 mg/dl, repeat = 1.93 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 46427ud00 and the complaint issue.The overall performance of magnesium was reviewed using field data from customers worldwide.The patient data was analyzed and shows the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified for lot 46427ud00.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the magnesium reagent for lot 46427ud00 was identified.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17418948
• Report Number: 3005094123-2023-00200
• Device Sequence Number: 13005754
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/11/2023

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: 09/29/2023
• Device Catalogue Number: 03P68-24
• Device Lot Number: 46427UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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, C402070; ARC C4000 INTGR, 02P24-40, C402070
• Patient Sex: Unknown