MAUDE Adverse Event Report: A.I.D.D LONGFORD MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number	08P1925
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).Patient information: no further information was provided.
Event or Problem Description
The customer obtained falsely elevated alinity c magnesium results.On (b)(6) 2022 sample id (b)(6).Generated an initial result of 3.35 mmol/l and repeat of 0.86 and 087 mmol/l.No impact to patient management was reported.
Event or Problem Description
On 29-mar-2022 the customer provided two additional falsely elevated alinity c magnesium results: sample id (b)(6): (b)(6) 2022 initial 3.90 mmol/l and repeat 1.01 mmol/l; sample id (b)(6) : (b)(6) 2022 initial 3.90 mmol/l and repeat 0.76 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Section b5 was updated to include two additional falsely elevated alinity c magnesium results.Section a1 patient identifier: multiple = (b)(6).Investigation of the customer's issue included review of complaint activity, trending data, labeling and device history records.Return testing was not completed as returns were not available.Review of the complaint information indicates quality controls were acceptable during the period the falsely elevated result was generated and retest of the samples generated the expected results.Review of complaint and trending data did not identify any issues or trends.Device history records were reviewed and did not identify any related non-conformances or deviations.Additionally, labeling was reviewed and sufficiently addresses the complaint issue.Based on this investigation, no systemic issue or deficiency was identified for the alinity c magnesium reagent lot.

• 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: 13765205
• Report Number: 3005094123-2022-00046
• Device Sequence Number: 4029720
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: 00380740176525
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/18/2022

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: 07/28/2022
• Device Model Number: 08P1925
• Device Catalogue Number: 08P19-25
• Device Lot Number: 32345UD00
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 PROCESSING MODU, 03R67-01, AC01132.; ALNTY C PROCESSING MODU, 03R67-01, AC01132.
• Patient Sex: Unknown