MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number 03P68-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: no specific patient information was provided.

Event Description

The customer observed a falsely elevated magnesium result on the architect c4000 analyzer.The sample generated an initial result 1.3778 mmol/l, repeat result 0.278 mmol/l further analysis confirmed that 0.278 mmol/l was the correct result.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 69367un19, which determined that there was no other complaints related to elevated results.A review of tracking and trending data for the architect magnesium assay identified no trends associated with the complaint issue.Return testing was not completed as returns were not available.Using worldwide field data the performance of reagent lot 69367un19 was evaluated and compared to an established control limit.This evaluation indicated that the patient median result for the reagent lot was within the established control limits.Therefore, no unusual reagent lot performance was identified.Manufacturing documentation including the certificate of analysis for the likely cause lot were reviewed and did not identify any issues associated with the complaint issue.The reagent lot was released within the final release specifications and met all acceptance requirements.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect magnesium assay was identified.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8957154
• MDR Text Key: 156483112
• Report Number: 1628664-2019-00594
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Catalogue Number: 03P68-21
• Device Lot Number: 69367UN19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LIST 02P24-40, SERIAL (B)(4); LIST 02P24-40, SERIAL (B)(4)