MAUDE Adverse Event Report: A.I.D.D LONGFORD 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	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6) (not enough characters in field to accommodate sid).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated magnesium result for a patient while running on the architect c16000 processing module.The following results were provided (normal range: 1.6-2.6 mg/dl): on (b)(6) 2022, sid (b)(6): initial result: 1.08 mg/dl.Repeat testing: 1.79, 1.14, 1.13 mg/dl.The customer was questioning the elevated magnesium result of 1.79 mg/dl.The customer then went and tested the sample on another architect for verification: on (b)(6) 2022, sid (b)(6): results were: 1.138, 1.110, 1.152, 1.119, 1.138, and 1.129 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated magnesium results included a search for similar complaints, and the review of complaint text, trending data, labeling, field data review, and device history records.Return testing was not performed as returns were not available.A reagent lot search did not identify an increase in complaint activity for the current issue.A review of tracking and trending did not identify any related trends for the product for the issue.File sample analysis was not performed.As part of troubleshooting, the patient sample was retested multiple times on the complaint instrument and a different instrument and gave similar lower results.In addition, the historical performance of reagent lot 39431ud00 was evaluated using world-wide data from customers in the field.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 39431ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 39431ud00.A review of the device history record did not identify any non-conformances or deviations associated with the reagent lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for magnesium reagent lot 39431ud00.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; 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: 15626417
• Report Number: 3005094123-2022-00226
• Device Sequence Number: 6224558
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 01/04/2023

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: 09/28/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 01/04/2023
• 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 C16K PRC MOD, 03L77-01, C1601970; ARC C16K PRC MOD, 03L77-01, C1601970
• Patient Sex: Unknown