MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-31

Device Problem High Test Results (2457)

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

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated magnesium result on the architect c8000 analyzer.The following data was provided for a male patient: (b)(6) initial 6.3, repeat 1.8 and 1.9 mg/dl.The sample was confirmed at 1.7 on another method.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.The sample was a serum sample in a becton dickinson (bd) gel tube and it was spun for 6 minutes at 4000 rpm, which exceeded the manufacturer's recommended force.Per the tube manufacturer, it is important to spin gel tubes for the recommended time of 10 minutes.The gel barrier in the tubes need time to move and form a solid barrier between the red cells and the serum.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7899908
• MDR Text Key: 121458014
• Report Number: 1628664-2018-01907
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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: 04/13/2020
• Device Catalogue Number: 07D70-31
• Device Lot Number: 99662UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LN 01G06-11 SN (B)(4); LN 01G06-11 SN (B)(4)