MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number 07D70-21

Device Problem High Test Results (2457)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Complete patient identifier: (b)(6) this issue was previously reported under mdr number 1415939-2019-00192 under the same suspect medical device but an incorrect manufacturer name, city and state.

Event Description

The customer reported a falsely elevated magnesium result generated on the architect c8000 analyzer on one patient.Results provided: sid (b)(6) on (b)(6) 2019 = 6.49 / 2.17 / 2.05 mg/dl; new tube= 2.01 mg/dl.Customers normal range: (1.8-2.6 mg/dl).No impact to patient management was reported.

Manufacturer Narrative

A review of complaints determined that there are no trends for the product list 7d70 for the complaint issue.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The evaluation of complaint data for the product and likely cause lot 72241un19 identified only one similar complaint.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9214509
• MDR Text Key: 192390499
• Report Number: 1628664-2019-00674
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• 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
• Report Date: 11/19/2019

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: 07D70-21
• Device Lot Number: 72241UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 LIST 01G06-11; ARCHITECT C8000 SYSTEM LIST 01G06-11; SERIAL (B)(4); SERIAL (B)(4)