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

Model Number 08P1934

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c magnesium results for multiple patient samples.The following data was provided (reference range 0.66 to 1.07 mmol/l): sample id (b)(6); initial result = 2.69 mmol/l, repeat = 0.84 mmol/l sample id (b)(6); initial result = 2.47 mmol/l, repeat = 0.82 mmol/l no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section patient identification: sids (b)(6).All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, a.I.D.D longford, lisnamuck, co.Longford, longford, ireland, n39e932 to alinity c processing module, list number 03r67-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2023-00037-00 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, to alinity c processing module, list number 03r67-01.Mdr number 3016438761-2023-00037-00 has been submitted and all further information will be documented under that mdr number.

• Brand Name: MAGNESIUM
• Type of Device: 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: 16045851
• MDR Text Key: 308471389
• Report Number: 3005094123-2022-00308
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-34
• Device Lot Number: 43489UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01901.; ALNTY C PROCESSING MODU, 03R67-01, AC01901.