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 Type  malfunction  

Manufacturer Narrative

On september 8, 2018, the suspect medical device changed from the architect c8000 analyzer to the magnesium reagents ln 7d70-31, lot 99662un18.This event has been previously reported in manufacturer report 1628664-2018-01791.All available patient information was included.Additional patient details are not available.An evaluation is still 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: sid (b)(6), initial 8.6, repeat 1.7, 1.7 mg/dl.The initial result was not reported out and there was no impact to patient management.

Manufacturer Narrative

The catalog size code was updated from 07d70-21 to 07d70-31.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.No return patient sample was available.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.Customer states that upon further lab investigation it was found that (b)(4) was not centrifuged on the track.Customer states that sample was spun on a stat centrifuge for 3 minutes at 10,000 rpm instead of 10 minutes.Customer added that the instrument is performing as expected, controls are within range, and likely cause is insufficient centrifugation.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: 7919762
• MDR Text Key: 123533125
• Report Number: 1628664-2018-01922
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• 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: 10/22/2018

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: 09/08/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/22/2018
• 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)