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

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10782794
• MDR Text Key: 214609012
• Report Number: 3002809144-2020-01080
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402797; ARC C4000 INTGR, 02P24-40, C402797; ARC C4000 INTGR, 02P24-40, C402797