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

Catalog Number	08P19-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium results generated on an alinity c processing module for multiple patients that repeated normal on another alinity.The following results were provided (normal range 1.6 ¿ 2.6 mg/dl): sid (b)(6) initial result = >9.50 mg/dl; repeat result = 2.50 mg/dl.Sid (b)(6) initial result = 6.01 mg/dl; repeat result = 2.05 mg/dl.Sid (b)(6) initial result = 9.50 mg/dl; repeat result = 1.89 mg/dl.Sid (b)(6) initial result = >9.50 mg/dl; repeat result = 1.98 mg/dl.There was no impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Additional information for section a1 patient identifier: (b)(6).All available patient information was included.Additional patient details are not provided.Additional information for section e1 phone number: (b)(6).
Event or Problem Description
The customer observed falsely elevated magnesium results generated on an alinity c processing module for multiple patients that repeated normal on another alinity.The following results were provided (normal range 1.6 ¿ 2.6 mg/dl): sid (b)(6) initial result = >9.50 mg/dl; repeat result = 2.50 mg/dl.Sid (b)(6) initial result = 6.01 mg/dl; repeat result = 2.05 mg/dl.Sid (b)(6) initial result = 9.50 mg/dl; repeat result = 1.89 mg/dl.Sid (b)(6) initial result = >9.50 mg/dl; repeat result = 1.98 mg/dl.There was no impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, abbott ireland diagnostics division, lisnamuck, longford, ireland, n39e932 to alinity c processing module, list number 03r67-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2023-00470 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 alinty c processing module, list number 03r67-01.Mdr number 3016438761-2023-00470 has been submitted and all further information will be documented under that mdr number.

• 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: 17596243
• Report Number: 3005094123-2023-00224
• Device Sequence Number: 17747980
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/01/2023

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 Catalogue Number: 08P19-34
• Device Lot Number: 52268UD00
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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, AC02933; ALNTY C PROCESSING MODU, 03R67-01, AC02933
• Patient Sex: Unknown