MAUDE Adverse Event Report: ABBOTT LABORATORIES MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 7D70-31

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).All available patient information was included.(b)(6).

Event Description

The customer observed a falsely decreased magnesium result for one patient on an architect c16000 analyzer.The following data was provided (customers reference range is 0.75-1.02 mmol/l): sample (b)(6) initial result was 0.24, repeated, under sample id (b)(6), was 0.77 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a falsely decreased architect magnesium result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the decreased result for the product.Return testing was not completed as returns were not available.Data provided by the customer showed that the retest result was acceptable using the same reagent and the issue is sample specific at the customer site, therefore, no file sample testing was performed.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency for the architect magnesium, lot number 08195un19, was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11058369
• MDR Text Key: 245181297
• Report Number: 3016438761-2020-00342
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (y/n): N
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2021
• Device Model Number: 7D70-31
• Device Catalogue Number: 07D70-31
• Device Lot Number: 08195UN19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1601082; ARC C16K PRC MOD, 03L77-01, C1601082; ARC C16K PRC MOD, 03L77-01, (B)(4)