MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-31

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that a falsely elevated architect magnesium result was generated for a patient sample.The sample initially tested at 6.2 mg/dl and retested at 2.1 mg/dl.The customer's normal range is 1.8 - 2.8 mg/dl.No adverse impact to patient management was reported.

Manufacturer Narrative

The customer declined any troubleshooting and requested service to resolve the issue.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the magnesium reagent lot.Labeling was reviewed and found to be adequate.Based on the available information, 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: 8185777
• MDR Text Key: 131796701
• Report Number: 1628664-2018-02170
• 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: 01/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Catalogue Number: 07D70-31
• Device Lot Number: 41651UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LIST 02P24-01, SERIAL (B)(4); LIST 02P24-01, SERIAL (B)(4)