MAUDE Adverse Event Report: ABBOTT LABORATORIES MAGNESIUM

Catalog Number 07D70-31

Device Problem High Test Results (2457)

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

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a falsely elevated magnesium (mg) result generated on the architect c8000 analyzer.Results provided: sid (b)(6), (b)(6) 2019 = 2.3 / 0.9 meq/l (normal range: 1.3-2.1 meq/l).There was no impact to patient management reported.

Manufacturer Narrative

It was discovered on october 18, 2019 that the initial emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 1628664-2019-00675 has been submitted for the correct manufacturing site and all further information will be documented under that mdr number.

Manufacturer Narrative

Return testing was not completed as returns were not available.A review of ticket trending and product lot number (72242un19) search did not identify any complaints that were similar for falsely elevated magnesium patient results.The trend review by the product list number found no trends related to this issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no product deficiency was identified.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8837657
• MDR Text Key: 195523753
• Report Number: 1415939-2019-00169
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (y/n): N
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

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: 02/01/2021
• Device Catalogue Number: 07D70-31
• Device Lot Number: 72242UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 08/21/2019; 10/18/2019
• Supplement Dates FDA Received: 08/21/2019; 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 SYSTEM LIST 01G06-11; ARCHITECT C8000 SYSTEM LIST 01G06-11; ARCHITECT C8000 SYSTEM LIST 01G06-11; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4)