MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	07D70-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2018
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.Due to field limitations an incomplete sample id was entered.Patient identifier.The complete entry is (b)(6).
Event or Problem Description
The customer reported a falsely elevated architect magnesium result for an (b)(6) male.Sample id (b)(6): initial 8.9 mg/dl, retest 2.9 mg/dl, retest alternate architect 2.0 mg/dl.A new sample was collected (sample id (b)(6)) generated 2.3 mg/dl.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there were no other complaints for lot 24857un17.Tracking and trending report review for the architect magnesium assay determined that there are no related adverse or non-statistical trends.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.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 MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7642498
• Report Number: 1628664-2018-00251
• Device Sequence Number: 14074027
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 11/13/2019
• Device Catalogue Number: 07D70-31
• Device Lot Number: 24857UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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 C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LIST 2P24, SERIAL (B)(4) ; LIST 2P24, SERIAL (B)(4)
• Patient Age: 81 YR