MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	07D70-21
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8268894
• Report Number: 1628664-2019-00045
• Device Sequence Number: 11312174
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 09/07/2020
• Device Catalogue Number: 07D70-21
• Device Lot Number: 95220UN18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1628664-01/8/19-001-C
• Patient Sequence Number: 1