MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-20

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated a false elevated magnesium 3.9 mmol/l on a sample that repeated 0.8 mmol/l when processing on the architect c16000.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

Upon retrospective review it was discovered that section.Date received by manufacturer was incorrect of 11sep2018 on followup 1.The correct date is 11oct2018.After further evaluation, the suspect medical device was changed to architect c16000, list 3l77 and submitted under manufacturer report number 1628664-2018-02110.All further information will be documented under that mdr number.Evaluation in process.

Manufacturer Narrative

The catalog number was updated from 07d70-20 to 03p68-21.The catalog number 03p68-21 is not marketed in the u.S.Therefore no mdr is needed for this event.No further followup for this event is needed.H3 other text : evaluation in process.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7950300
• MDR Text Key: 125285678
• Report Number: 1628664-2018-01935
• 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,Followup
• Report Date: 12/04/2018

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 Catalogue Number: 07D70-20
• Device Lot Number: 32990UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 09/11/2018; 12/04/2018
• Supplement Dates FDA Received: 11/03/2018; 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 LIST 03L77-01; ARCHITECT C16000 LIST 03L77-01; ARCHITECT C16000 LIST 03L77-01; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4)