MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number 03P68-21

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false elevated magnesium results when processing on the architect c4000.The following data was provided: sample 1: initial 6.10 and retests were 1.71 and 1.71 mg/dl.The customer uses a normal range of 1.60-2.06 mg/dl.The patient had imaging exams and there was no harm to the patient reported.No additional impact to patient management was reported.

Manufacturer Narrative

On 14jan2020,, the suspect medical device was updated from list 03p68-21 to list 02p24-01.All further information regarding this event will be sent in manufacturer report number 1628664-2020-00046, for the new suspect medical device.No additional information for this event will be submitted in this manufacturer report number (1628664-2019-00759).

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9462373
• MDR Text Key: 219215188
• Report Number: 1628664-2019-00759
• Device Sequence Number: 1
• Product Code: JGJ
• 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: 02/10/2020

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 Catalogue Number: 03P68-21
• Device Lot Number: 54408UQ01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000, LIST 02P24-01; SERIAL (B)(6)