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

Model Number	7D70-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 12689731
• Report Number: 3016438761-2021-00394
• Device Sequence Number: 19875132
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 7D70-21
• Device Catalogue Number: 07D70-21
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, C402777; ARC C4000 INTGR, 02P24-40, C402777; ARC C4000 INTGR, 02P24-40, C402777