MAUDE Adverse Event Report: A.I.D.D LONGFORD 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	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated magnesium result generated on the alinity c processing module (b)(4) for one sample.On (b)(6) 2021 sid (b)(6) initial result on (b)(4) (lot 82496un21) = 0.66 mmol/l, repeat = 0.51 mmol/l, repeats on (b)(4) = 0.51 mmol/l and 0.50 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.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c 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 lots 28011ud00 and 82496un21 and the complaint issue.The overall performance of alinity c magnesium was reviewed using field data from customers worldwide and suggests that the product is performing acceptably.Also review of the data associated with reagent lots 28011ud00 and 82496un21, indicates the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified with reagent lots 28011ud00 and 82496un21.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c magnesium reagent for lots 28011ud00 and 82496un21 was identified.Updated section g1 for updated contact information.Updated section b5 to include clarifiying information about lot numbers.Updated section d4 as catalog no changed from 08p19-34 to 08p19-30.
Event or Problem Description
The customer observed a falsely elevated magnesium result generated on the alinity c processing module for one sample.The following data was provided (b)(6) 2021: sid (b)(6) initial result = 0.5 mmol/l on ac03519, repeat on ac03518 (lot 28011ud00) = 1.2 mmol/l.Additional data was provided by the customer: the customer observed a falsely elevated magnesium result generated on the alinity c processing module (ac03518) for an additional sample.(b)(6) 2021: sid (b)(6) initial result on ac03518 (lot 82496un21) = 0.66 mmol/l, repeat = 0.51 mmol/l, repeats on ac03678 = 0.51 mmol/l and 0.50 mmol/l no impact to patient management was reported.

• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13201037
• Report Number: 3005094123-2022-00010
• Device Sequence Number: 5861332
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/17/2022

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: 03/10/2022
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-30
• Device Lot Number: 82496UN21
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/09/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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 MAG (3600T), 08P19-34, 28011UD00; ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown