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

Catalog Number 03P68-24

Device Problem High Test Results (2457)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated magnesium results generated on the architect c16000 processing module for two samples that were not released out of the lab.The following results were provided: (b)(6) original result = 3.6671 mmol/l, repeat result = 0.9396 mmol/l (b)(6) original result = >3.9 mmol/l, repeat result = 0.9196 mmol/l reference (normal) ranges: 0.66 to 1.07 mmol/l no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier: (b)(6) and (b)(6).

Event Description

The customer observed falsely elevated magnesium results generated on the architect c16000 processing module for two samples that were not released out of the lab.The following results were provided: sid (b)(6) original result = 3.6671 mmol/l, repeat result = 0.9396 mmol/l sid (b)(6) original result = >3.9 mmol/l, repeat result = 0.9196 mmol/l reference (normal) ranges: 0.66 to 1.07 mmol/l no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect magnesium reagent kit, lot number 51199ud00, was identified.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name g1-contact office last name g1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17650631
• MDR Text Key: 322284686
• Report Number: 3005094123-2023-00232
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Catalogue Number: 03P68-24
• Device Lot Number: 51199UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)