MAUDE Adverse Event Report: ABBOTT LABORATORIES 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
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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8837657
• Report Number: 1415939-2019-00169
• Device Sequence Number: 11376921
• 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,Followup,Followup
• 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
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 10/18/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/21/2019; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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)