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

Catalog Number 08P19-34

Device Problem Low Test Results (2458)

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

Event Date 07/27/2023

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 323325862
• Report Number: 3005094123-2023-00237
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 08P19-34
• Device Lot Number: 47345UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/05/2023
• 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, AC02156; ALNTY C PROCESSING MODU, 03R67-01, AC02156