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 Type  malfunction  

Manufacturer Narrative

A product correction letter was issued to all magnesium customers who have received one of the impacted lots.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.

Event Description

The customer reported magnesium urine controls shifted low out of range while using the architect urine magnesium assay.During troubleshooting the customer retested previously tested cap survey samples and all the mg urine results were decreased from the original results.No impact to patient management was reported.

• 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: 8268894
• MDR Text Key: 134717345
• Report Number: 1628664-2019-00045
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2020
• Device Catalogue Number: 07D70-21
• Device Lot Number: 95220UN18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2018
• 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