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	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for one sample that was not released out of the lab.The following results were provided: sid (b)(6) original result = 7.5 mg/dl, rerun result on another architect = 1.9 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids(b)(6) all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for one sample that was not released out of the lab.The following results were provided: sid (b)(6)original result = 7.5 mg/dl, rerun result on another architect = 1.9 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated 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.Return testing was not completed as returns were not available.Instrument troubleshooting including cleaning the cuvettes, rebuilding reagent and sample syringes, and other adjustments/replacements were performed.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 27365un22 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the magnesium assay for lot 27365un22 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17265847
• Report Number: 3002809144-2023-00300
• Device Sequence Number: 12754185
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/15/2023

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: 10/05/2023
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 27365UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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, C402248; ARC C4000 INTGR, 02P24-40, C402248
• Patient Sex: Unknown