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

Model Number	03P6824
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.  section a1 - patient identifier complete entry =(b)(6).Section e1 - phone complete entry = (b)(6).
Event or Problem Description
The customer observed falsely elevated magnesium (mg) results generated on the architect c4000 for a patient sample.The following data was provided (customer¿s reference range 1.8 - 2.6 mg/dl): sample id 206627952801 initial result = 7.37 mg/dl, repeat = 2.08 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section: d4 - expiration date and h4 - device mfg date.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.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the complaint lot.The overall performance of architect magnesium reagents was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 39431ud00.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect magnesium reagent kit, lot number 39431ud00, was identified.
Event or Problem Description
The customer observed falsely elevated magnesium (mg) results generated on the architect c4000 for a patient sample.The following data was provided (customer¿s reference range 1.8 - 2.6 mg/dl): sample id (b)(6) initial result = 7.37 mg/dl, repeat = 2.08 mg/dl no impact to patient management was reported.

• 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: 16672698
• Report Number: 3005094123-2023-00085
• Device Sequence Number: 20177936
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 03/14/2023
• Device Model Number: 03P6824
• Device Catalogue Number: 03P68-24
• Device Lot Number: 39431UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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