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

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation 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.The patient sample was reanalyzed using the same reagent with no issues; acceptable results were generated.A review of tickets determined that there is normal complaint activity for lot 35289un20.Review of tracking and trending reports did not identify any related trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent, lot number 35289un20 was identified.
Event or Problem Description
The customer reported falsely elevated magnesium results generated on the architect c8000 processing module for two patients.The results provided from the samples collected on (b)(6) 2020 were: patient 1 initial result was 6.3 mg/dl, repeated 1.9 mg/dl; patient 2 initial result was 6.3 mg/dl, repeated 1.9 mg/dl; (customer reference range 1.7 mg/dl to 2.8 mg/dl).No impact to patient management was reported.

• 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: 11021520
• Report Number: 3002809144-2020-01191
• Device Sequence Number: 19507994
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 03/03/2021
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 35289UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1