MAUDE Adverse Event Report: ABBOTT LABORATORIES MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 7D70-21

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifiers and date of event: date the incident occurred: sid (b)(6) : (b)(6) 2021.Sid (b)(6) : (b)(6) 2021.Patient (b)(6) (sid not provided): (b)(6) 2021.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated magnesium results generated on an architect c4000 analyzer for four patients.The following results were provided: sid (b)(6) initial result = 2.59 mmol/l; repeat result = 0.81 mmol/l.Sid (b)(6) initial result = 3.87 mmol/l; repeat result = 0.94 mmol/l.Patient (b)(6) (sid not provided) initial result = 3.5 mmol/l; repeat result - 0.7 mmol/l.Patient (b)(6) (sid not provided) initial result = 2.6 mmol/l; repeat result = 1.0 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from magnesium, list number 07d70-21, (b)(6) to magnesium, list number 03p68-22, abbott gmbh, max-plank-ring 2, wiesbaden, germany, 65205.Mdr number 3002809144-2021-00635 has been submitted and all further information will be documented under that mdr number.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 12689731
• MDR Text Key: 278158312
• Report Number: 3016438761-2021-00394
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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 Model Number: 7D70-21
• Device Catalogue Number: 07D70-21
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402777; ARC C4000 INTGR, 02P24-40, C402777; ARC C4000 INTGR, 02P24-40, C402777