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

Catalog Number	08P19-34
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported erratic magnesium results generated from an alinity c processing module (sn: ac02156) and provided the following data for 1 patient.(customer normal range 1.5 -2.5 mg/dl on (b)(6) 2023 sample id(b)6) generated a result of 0.99 and repeat results were 1.03 and 1.0.Repeated on another alinity c processing module (sn: ac02157) generated a result of 1.59.There was no reported impact to patient management.
Additional Manufacturer Narrative
E1 phone: (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 reported erratic magnesium results generated from an alinity c processing module (sn: (b)(6)) and provided the following data for 1 patient.(customer normal range 1.5 -2.5 mg/dl.On (b)(6) 2023 sample id (b)(6) generated a result of 0.99 and repeat results were 1.03 and 1.0.Repeated on another alinity c processing module (sn: (b)(6)) generated a result of 1.59.There was no reported impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity c magnesium reagent, list number:08p19-34, and manufacturing site: abbott ireland diagnostics division, lisnamuck, longford, ireland, n39e932 to alinity c processing module, ln 03r67-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2023-00530 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 alinity c magnesium reagent, list number:08p19-34 to alinity c processing module, ln 03r67-01.Mdr number 3016438761-2023-00530 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: 17725707
• Report Number: 3005094123-2023-00237
• Device Sequence Number: 12549806
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/05/2023

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: 47345UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/05/2023
• 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, AC02156; ALNTY C PROCESSING MODU, 03R67-01, AC02156
• Patient Sex: Unknown