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

Model Number 03P6832

Device Problem High Test Results (2457)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6).Reporter email (unable to populate due to the limit of characters to this field).Submitter email address: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated magnesium result for a patient while running on architect c8000 processing module.The following data was provided (customer¿s normal range: 1.6 ¿ 2.6 mg/dl (16-26 mg/l)): sid (b)(6)= initial result = 8.61 mg/dl (86.1 mg/l) / repeat result = 2.02 mg/dl (20.2 mg/l), 2.07 mg/dl (20.7 mg/l) there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false elevated magnesium results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Ticket review determined that there is normal complaint activity for lot number 81717un21.The trending review determined no trends identified for falsely elevated patient results for the product.File sample analysis was not performed as samples when retested, generated lower normal results.The preventative maintenance log was okay and quality controls were within range during the time of testing.Worldwide data was reviewed and determined that the patient median result for magnesium reagent lot number 81717un21 is within established control limits, indicating the assay is performing as expected.A review of the device history record did not identify any non-conformances or deviations.Labeling was reviewed and was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of magnesium reagent, lot number 81717un21 was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12469074
• MDR Text Key: 277991333
• Report Number: 3002809144-2021-00568
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 81717UN21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8000 REFURB-SEKAT, 01G06-97, (B)(6); ARC C8000 REFURB-SEKAT, 01G06-97, (B)(6)