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

Model Number	08P1934
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete sample id is (b)(6).All available patient information was 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 observed falsely elevated magnesium result generated from an alinity c processing module on (b)(6) 2023 and provided the following data for 1 patient: (reference range: 0.66 to 1.07 mmol/l) sample id (b)(6) initial result on analyzer sn:(b)(6) was 2.89 mmol/l.Repeat result on another alinity c processing module (sn: (b)(6)) was 0.56 mmol/l.Repeat on the original analyzer sn: (b)(6) was 0.52 mmol/l the customer then performed a 10 repeat testing of the patient sample on the original analyzer sn:(b)(6) on (b)(6) 2023, which generated the following results: 0.54, 0.54, 0.55, 0.54, 0.54, 0.54, 0.55, 0.56, 0.53, 0.56 the customer reported that the discrepant result was not reported to the patient¿s medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer observed falsely elevated magnesium result generated from an alinity c processing module on 8 july 2023 and provided the following data for 1 patient: (reference range: 0.66 to 1.07 mmol/l).Sample id (b)(6) initial result on analyzer sn:(b)(6) was 2.89 mmol/l.Repeat result on another alinity c processing module (sn: (b)(6)) was 0.56 mmol/l.Repeat on the original analyzer sn:(b)(6) was 0.52 mmol/l.The customer then performed a 10 repeat testing of the patient sample on the original analyzer sn:(b)(6) on (b)(6) 2023, which generated the following results: 0.54, 0.54, 0.55, 0.54, 0.54, 0.54, 0.55, 0.56, 0.53, 0.56.The customer reported that the discrepant result was not reported to the patient¿s medical provider.There was no reported impact to patient management.
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, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the alinity c magnesium reagents in the field was reviewed using data gathered from customers worldwide.The review of field data determined the median values are within the established limits for reagent lot 49641ud00.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c magnesium reagent lot number 49641ud00 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: 17370650
• Report Number: 3005094123-2023-00182
• Device Sequence Number: 11731205
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 12/21/2023
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-34
• Device Lot Number: 49641UD00
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown