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

Catalog Number 08P19-34

Device Problem High Test Results (2457)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated magnesium result generated on the alinity c processing module for one sample.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 6.35 mmol/l, repeat on an architect = 0.86 mmol/l no impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, longford to alinity c processing module, 03r67-01, irving ia/cc.Mdr number 3016438761-2024-00007-00 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, longford to alinity c processing module, 03r67-01, irving ia/cc.Mdr number 3016438761-2024-00007-00 has been submitted and all further information will be documented under that mdr number.

Event Description

The customer observed a falsely elevated magnesium result generated on the alinity c processing module for one sample.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 6.35 mmol/l, repeat on an architect = 0.86 mmol/l no impact to patient management was reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18029935
• MDR Text Key: 327330873
• Report Number: 3005094123-2023-00285
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/04/2024

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: 52268UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/04/2024
• 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, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)