MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number	07D70-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete sid = (b)(6).All available patient information was included.Additional patient details are not available.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.This issue was previously reported under mdr number 1415939-2019-00169 under the same suspect medical device but an incorrect manufacturer name, city and state.
Event or Problem Description
The customer reported a falsely elevated magnesium (mg) result generated on the architect c8000 analyzer.Results provided: sid (b)(6) on (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.

• Brand Name: MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9214936
• Report Number: 1628664-2019-00675
• Device Sequence Number: 2524296
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 07D70-31
• Device Lot Number: 72242UN19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1