MAUDE Adverse Event Report: ABBOTT GERMANY CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	03P68-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.No specific patient information was provided by the customer.
Event or Problem Description
The customer reported falsely elevated architect magnesium results.The sample generated an initial result of 2.97 mmol/l and retest of 0.86 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity for lot 46459un18 found no other complaints related to the customer's issue.Tracking and trending data review for the architect magnesium assay did not identify any trends.Using worldwide field data the historical performance of reagent lot 46459un18 was evaluated.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 46459un18 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Manufacturing documentation for the lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect magnesium assay was identified.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8609105
• Report Number: 3002809144-2019-00291
• Device Sequence Number: 16565436
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 11/08/2019
• Device Catalogue Number: 03P68-32
• Device Lot Number: 46459UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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: ARCHITECT C160000, LIST# 03L77-01; ARCHITECT C160000, LIST# 03L77-01; SERIAL # C1600770; SERIAL # C1600770