MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-21

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

A product correction letter was issued to all magnesium customers who have received one of the lots listed below.The letter instructs the customer to discontinue use of the magnesium urine application.New customers will receive product with a kit stuffer that includes instructions to immediately discontinue use of the 7d70 magnesium urine application.This correction includes the following medical device, clin chem magnesium list 07d70-21: udi (b)(4), lots: 79865un17 dom 22mar2017 / exp 09mar2019; 12921un17 dom 25may2017 / exp 03may2019; 43618un17 dom 29jun2017 / exp 09jun2019; 45337un2017 dom 11aug2017 / exp 14jul2019; 84994un17 dom 30oct2017 / exp 12oct2019; 24856un17 dom 01dec2017 / exp 13nov2019; 41652un2018 dom 08feb2018 / exp 29jan2020; 99639un18 dom 14mar2018 / exp 26feb2020; 99661un18 dom 14may2018 / exp 13apr2020; 78493un18 dom 10aug2018 / exp 25jul2020; 95220un18 dom 13oct2018 / exp 07sep2020; 31428un18 dom 26nov2018 / exp 31oct2020; 33784un2018 dom 19jul2018 / exp 11jun2020.List 7d70-31: udi (b)(4), lots: 36339un17 dom 25jan2017 / exp 06jan2019; 97389un17 dom 28mar2017 / exp 09mar2019; 12922un17 dom 25may2017 / exp 03may2019; 43616un17 dom 29jun2017 / exp 09jun2019; 45338un17 dom 10aug2017 / exp 14jul2019; 84993un17 dom 21sep2017 / exp 01sep2019; 08788un17 dom 27oct2017 / exp 12oct2019; 24857un17 dom 01dec2017 / exp 13nov2019; 41651un18 dom 08feb2018 / exp 29jan2020; 99640un18 dom 14mar2018 / exp 26feb2020; 99662un18 dom 15may2018 / exp 13apr2020; 33783un18 dom 07jun2018 / exp 09may2020; 33785un18 dom 19jul2018 / exp 11jun2020; 78859un18 dom 15aug2018 / exp 25jul2020; 95341un18 dom 13oct2018 / exp 07sep2020; 31429un18 dom 26nov2018 / exp 31oct2020.

Event Description

On 11/30/2018, an abbott internal magnesium urine linearity study confirmed the performance of the magnesium urine application (list numbers 7d70-21 and 7d70-31) exceeds the bias expectation of 10% (or 0.2 meq/l).As a result, there is a potential for falsely depressed results since all urine samples > 0.5 meq/l demonstrate depressed recovery of up to 37%.There is no impact to magnesium plasma/serum results.There was no reported impact to patient management.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8247874
• MDR Text Key: 133867751
• Report Number: 1628664-2018-02195
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/15/2019

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: 01/06/2019
• Device Catalogue Number: 07D70-21
• Device Lot Number: 36338UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-01/8/19-001-C
• Patient Sequence Number: 1