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

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = sample id (b)(4) and sample id (b)(4).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated magnesium result for two patients on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 1.60-2.60 mg/dl): sample id (b)(4) initial result was 8.14, repeat was 2.11 mg/dl sample id (b)(4) initial result was 3.2, repeat was 1.3, repeated on another analyzer was 1.2 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the increased result for the product.Return testing was not completed as returns were not available.Decontamination process was performed to remove the contamination/growth observed around water/air line of water bath after which magnesium precision was performed and was within specification.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency for the architect magnesium, lot number 86785un21, was identified.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12058248
• Report Number: 3002809144-2021-00390
• Device Sequence Number: 3502689
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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 Expiration Date: 03/08/2022
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 86785UN21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/06/2021
• 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, C402832; ARC C4000 INTGR, 02P24-40, C402832; ARC C4000 INTGR, 02P24-40, C402832