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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2020
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.
Event or Problem Description
The customer reported falsely elevated magnesium results for 3 patients while running on the architect c4000 processing module.The customer was only able to provide discrepant results for one patient.The following data was provided (customer's reference range: 1.3 to 2.1 mg/dl): sid: (b)(6) = initial result = 6.25 mg/dl, repeat = 1.43, 1.4 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for architect magnesium reagent ln 3p68-32/lot number 85056un20.Trending review identified no trends for discrepant patient results for the product.Return testing was not completed as returns were not available.Worldwide data was reviewed and determined that the patient median result for magnesium reagent lot number 85056un20 is within established control limits.Retesting of the sample gave expected normal results.A review of the manufacturing documentation did not identify any non-conformances or deviations associated with the complaint issue.A review of the product labeling determined that the issue was adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent lot number 85056un20 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: 10782794
• Report Number: 3002809144-2020-01080
• Device Sequence Number: 11712084
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 06/25/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 85056UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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, C402797; ARC C4000 INTGR, 02P24-40, C402797; ARC C4000 INTGR, 02P24-40, C402797