MAUDE Adverse Event Report: ABBOTT LABORATORIES 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).

Event Description

The customer reported a falsely elevated magnesium result generated on the architect c8000 analyzer on one patient.Results provided: sid (b)(6), (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

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 1628664-2019-00674 has been submitted for the correct manufacturing site and all further information will be documented under that mdr number.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9086245
• MDR Text Key: 159353064
• Report Number: 1415939-2019-00192
• 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: 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 Catalogue Number: 07D70-21
• Device Lot Number: 72241UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 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; SERIAL (B)(4); SERIAL (B)(4)