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

Catalog Number 03P68-34

Device Problem High Test Results (2457)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated magnesium results for several patients on an architect c8000 analyzer.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id (b)(6); initial result was 6.8, repeat result was 1.9 mg/dl.Sample id (b)(6); initial result was 6.7, repeat result was 1.8 mg/dl.Sample id (b)(6); initial result was 7.2, repeat result was 2.5 mg/dl.Sample id (b)(6); initial result was 6.8, repeat result was 2.0 mg/dl.Sample id (b)(6); initial result was 6.7, repeat result was 1.9 mg/dl.Sample id (b)(6); initial result was 6.9, repeat result was 2.2 mg/dl.There was no impact to patient management reported.

Event Description

The customer observed falsely elevated magnesium results for several patients on an architect c8000 analyzer.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id (b)(6) initial result was 6.8, repeat result was 1.9 mg/dl.Sample id (b)(6) initial result was 6.7, repeat result was 1.8 mg/dl.Sample id (b)(6) initial result was 7.2, repeat result was 2.5 mg/dl.Sample id (b)(6) initial result was 6.8, repeat result was 2.0 mg/dl.Sample id (b)(6) initial result was 6.7, repeat result was 1.9 mg/dl.Sample id (b)(6) initial result was 6.9, repeat result was 2.2 mg/dl.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a falsely elevated magnesium result on an architect c8000 analyzer 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.Trending review determined no related trend for the issue for the product.As part of the troubleshooting, all samples were repeated on another analyzer with same reagent lot and generated lower normal results.The technician discarded the questionable reagent kit and has not had any further discrepant results.The quality control results were high prior to the discrepant results being generated; however, the reagent was recalibrated, and quality control results were then performing within the expected ranges, which shows that the assay was performing as expected.Additionally, the field service engineer found the 1ml syringe on the wash solution pump was installed incorrectly.The fse replaced both 1ml syringes, check valves, cuvette dry tip due to discoloration, and performed light path alignment, cuvette washer alignment, mixer alignment, sample/r1/r2 pipettor calibrations, and flushed fluids and performed cuvette washer test.After that, the instrument returned to normal function.No additional issues were identified.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of the magnesium reagent, lot number 54910ud00, was identified.

• 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: 19073341
• MDR Text Key: 340596470
• Report Number: 3005094123-2024-00179
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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 Expiration Date: 05/04/2024
• Device Catalogue Number: 03P68-34
• Device Lot Number: 54910UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, (B)(6) ; ARC C8 PROC MOD, 01G06-11, (B)(6)