MAUDE Adverse Event Report: A.I.D.D LONGFORD MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 08P1934

Device Problem High Test Results (2457)

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

Event Date 10/20/2021

Event Type  malfunction  

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) 2021 sid (b)(6) initial result = 0.5 mmol/l on ac03519, repeat on ac03518 = 1.2 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow up will be submitted when the evaluation is complete.No further information was provided.

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) 2021.Sid (b)(6) initial result = 0.5 mmol/l on ac03519, repeat on ac03518 (lot 28011ud00) = 1.2 mmol/l additional data was provided by the customer: the customer observed a falsely elevated magnesium result generated on the alinity c processing module (ac03518) for an additional sample.08dec2021 sid 5356323 initial result on ac03518 (lot 82496un21) = 0.66 mmol/l, repeat = 0.51 mmol/l, repeats on ac03678 = 0.51 mmol/l and 0.50 mmol/l no impact to patient management was reported.

Manufacturer Narrative

Correction of section g3 date received by mfg was documented as 02/15/2021 and it was on 02/15/2022.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lots 28011ud00 and 82496un21 and the complaint issue.The overall performance of alinity c magnesium was reviewed using field data from customers worldwide and suggests that the product is performing acceptably.Also review of the data associated with reagent lots 28011ud00 and 82496un21, indicates the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified with reagent lots 28011ud00 and 82496un21.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c magnesium reagent for lots 28011ud00 and 82496un21 was identified.Updated section g1 for updated contact information.Updated section b5 to include clarifying information about lot numbers.

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) 2021 sid (b)(6) initial result = 0.5 mmol/l on ac03519, repeat on ac03518 (lot 28011ud00) = 1.2 mmol/l.Additional data was provided by the customer: the customer observed a falsely elevated magnesium result generated on the alinity c processing module (ac03518) for an additional sample.(b)(6) 2021 sid (b)(6) initial result on ac03518 (lot 82496un21) = 0.66 mmol/l, repeat = 0.51 mmol/l, repeats on ac03678 = 0.51 mmol/l and 0.50 mmol/l no impact to patient management was reported.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; 100 abbott park road; post market surveillance; abbott park, IL 60064--353 ; 2246682940
• MDR Report Key: 12781708
• MDR Text Key: 283599006
• Report Number: 3005094123-2021-00204
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-34
• Device Lot Number: 28011UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C MAGNESIUM 3600T, 08P19-30, 82496UN21; ALNTY C MAGNESIUM 3600T, 08P19-30, 82496UN21; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)