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	07/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: complete list of sample id's are (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 observed falsely elevated magnesium results generated from an alinity c processing module on (b)(6), 2023.The customer reported that healthcare providers have questioned the results and when repeated, the elevated results were normal.The customer provided the following data: customer normal range is 1.6- 2.6 ng/dl.Sample id (b)(6), initial result was 6.2 and repeat on another analyzer was 2.4, sample id (b)(6), initial result was 6.0 and repeat on another analyzer was 1.9, sample id (b)(6), initial result was 6.0 and repeat on another analyzer was 1.5, sample id (b)(6), initial result was 6.0 and repeat on another analyzer was 2.5.The customer performed some troubleshooting, such as changing probes on the analyzer and afterwards performed a precision study on a sample that reported at 1.8.The precision results were 8.3, 2.2, 1.7, 1.6, 1.6, 1.7, 1.6, 1.8, 2.0, 1.7.There was no reported impact to patient management.
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (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.After further evaluation, the suspect medical device was changed from magnesium reagent kit, 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 3016438761-2023-00484 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 reagent kit, list number:08p19-34 to alinity c processing module, ln 03r67-01.Mdr number 3016438761-2023-00484 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed falsely elevated magnesium results generated from an alinity c processing module on 23 july 2023.The customer reported that healthcare providers have questioned the results and when repeated, the elevated results were normal.The customer provided the following data: customer normal range is 1.6- 2.6 ng/dl sample id (b)(6) initial result was 6.2 and repeat on another analyzer was 2.4.Sample id (b)(6) initial result was 6.0 and repeat on another analyzer was 1.9.Sample id (b)(6) initial result was 6.0 and repeat on another analyzer was 1.5.Sample id (b)(6) initial result was 6.0 and repeat on another analyzer was 2.5.The customer performed some troubleshooting, such as changing probes on the analyzer and afterwards performed a precision study on a sample that reported at 1.8.The precision results were 8.3, 2.2, 1.7, 1.6, 1.6, 1.7, 1.6, 1.8, 2.0, 1.7.There was no reported impact to patient management.

• 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: 17547474
• Report Number: 3005094123-2023-00216
• Device Sequence Number: 17856157
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 07/23/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/11/2023
• 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, AC01523; ALNTY C PROCESSING MODU, 03R67-01, AC01523
• Patient Sex: Unknown