MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number	07D70-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer generated falsely elevated magnesium result while using the clinical chemistry magnesium assay.The customer provided the following result data (customer reference range for mg (1.6 - 2.6) mg/dl: on (b)(6) 2019: initial: 2.5 mg/dl, retests 1.1 mg/dl and 1.1 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Return material was not available.Tracking and trending did not identify an adverse trend for discrepant clinical chemistry magnesium results.The capa review determined that there are no events, defects or issues that were associated with the performance of the likely cause list in relation to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the clinical chemistry magnesium assay, ln 07d70, lot 45722un18, was identified.

• Brand Name: MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8546603
• Report Number: 1628664-2019-00335
• Device Sequence Number: 1744061
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 12/03/2020
• Device Catalogue Number: 07D70-21
• Device Lot Number: 45722UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-40, SN C401548; LN 02P24-40, SN C401548