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	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium flier on an architect c4000 processing module for a patient.Results were not reported to the medical provider.Sid number or reference range was not available.The following patient data was provided initial magnesium result = 2.88 mmol/l, repeat from another analyzer= 0.9 mmol/l, repeat on this instrument: 0.88, 0.88 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included, no additional patient information was available.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not performed as returns were not available.Device history record review was performed on lot number 64202ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.A search for similar tickets by lot number 64202ud00 found normal complaint activity.File sample analysis was not performed as the issue appears to be specific to the documented patient sample.Sample was rerun on another analyzer and on the same instrument with same reagent lot and generated lower results.In addition, the quality control was acceptable during the erratic result.This indicates the assay is performing as expected.Labeling was found to be adequate for the issue under review.Based on the information within the complaint record, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed falsely elevated magnesium flier on an architect c4000 processing module for a patient.Results were not reported to the medical provider.The following patient data was provided by the customer.The customer is not able to provide the sample id# nor the reference range.Initial magnesium result = 2.88 mmol/l, repeat from another analyzer= 0.9 mmol/l, repeat on this instrument: 0.88, 0.88 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
This follow-up submission being send to cross reference mdr 3005094123-2024-00576-00 for likely cause changed on 24nov2024; magnesium reagent, list # 03p68-24 to architect c4000 processing module, list number 02p24-01.All further information will be submitted under mdr 3016438761-2024-00705-00.
Event or Problem Description
The customer observed falsely elevated magnesium flier on an architect c4000 processing module for a patient.Results were not reported to the medical provider.The following patient data was provided by the customer.The customer is not able to provide the sample id# nor the reference range.Initial magnesium result = 2.88 mmol/l, repeat from another analyzer= 0.9 mmol/l, repeat on this instrument: 0.88, 0.88 mmol/l.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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20610316
• Report Number: 3005094123-2024-00576
• Device Sequence Number: 15285653
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: (01)00380740169855(17)250313(10)64202UD00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 12/10/2024

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: 03/13/2025
• Device Catalogue Number: 03P68-24
• Device Lot Number: 64202UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 11/24/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/20/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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 C4 PROC MOD, 02P24-01, (B)(6); ARC C4 PROC MOD, 02P24-01, (B)(6); ARC C4 PROC MOD, 02P24-01, (B)(6)
• Patient Sex: Unknown