MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	03P68-21
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false elevated magnesium initial result of 2.73 mmol/l, when processing on the architect c16000.The retest results were 0.75 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Suspect medical device catalog number was updated from 7d70-21 to 03p68-21.Suspect medical device lot number was updated from unknown to 12548un18.An investigation was performed for the customer issue and included a review of the complaint text, search for similar complaints, review of trending data, a review of historical data, and a review of product labeling.No atypical complaint trends were identified for list number 3p68.No historical or on-going investigations of magnesium list number 3p68 for the customer issue were identified.Review of historical data shows the median population results for this lot are within established baselines.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 8340754
• Report Number: 1628664-2019-00130
• Device Sequence Number: 16573462
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K981791
• 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): 05/08/2019

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: 09/20/2019
• Device Catalogue Number: 03P68-21
• Device Lot Number: 12548UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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 C16000 ANALYZER, LN 03L77-97; ARCHITECT C16000 ANALYZER, LN 03L77-97; SERIAL C1600573; SERIAL C1600573