MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 03P68-21

Device Problem High Test Results (2457)

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

Event Date 11/25/2018

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 reported a falsely elevated architect magnesium initial result of 7.18 mg/dl.Repeat result was 1.88 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed by reviewing the complaint text, service history, tracking and trending metrics, and the current labeling for the magnesium package insert and the architect system operations manual.Review of complaint activity did not identify other complaints for the likely cause lot 99555un18.Tracking and trending for the magnesium assay determined there were no adverse or non-statistical trends.No nonconformances were identified related to this issue.A review of the product labeling concluded that the issue is sufficiently addressed.No systemic issue or deficiency of the architect magnesium assay was identified.

Manufacturer Narrative

An error was identified on march 05, 2019.The manufacturer location in this submission is incorrectly identified as abbott laboratories, abbott park il.The correct manufacturing location is abbott manufacturing inc, irving tx.Manufacturer report number 1628664-2019-00264 has been submitted with the correct location and all further information will be provided under that mdr report number.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8174207
• MDR Text Key: 131771017
• Report Number: 1415939-2018-00168
• 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,Followup
• Report Date: 03/29/2019

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: 03/26/2019
• Device Catalogue Number: 03P68-21
• Device Lot Number: 99555UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/11/2019; 03/05/2019
• Supplement Dates FDA Received: 02/01/2019; 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000, LIST 02P24-40; ARCHITECT C4000, LIST 02P24-40; ARCHITECT C4000, LIST 02P24-40; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4)