MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	07D70-21
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
Patient identifier: multiple = sid (b)(6), sid (b)(6).An evaluation is in process.A final report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated magnesium results generated on the architect analyzer for two patients.The results provided were: sid (b)(6): first architect = 2.1 / repeated on second architect = 1.4 /1.3mg/dl (normal range 1.6 - 2.6mg/dl); sid (b)(6): first architect =2.0 / repeat on second architect = 1.3 / 1.2mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
The customer contacted abbott on 09feb2019 to indicate discrepant patient results when using the magnesium assay, lot number 95220un18.The customer indicated initial false elevated results and subsequent results were within normal range.All qc results were within range on the date of testing.Returns were available but not necessary for the investigation.A review of all complaints associated with the magnesium assay, lot 95220un18, and a review for complaint trends and corrective and preventative actions for the list number was performed.The review did not identify any trends that required further investigation.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the magnesium assay, lot 95220un18.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8378820
• Report Number: 1628664-2019-00171
• Device Sequence Number: 1332943
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 09/07/2020
• Device Catalogue Number: 07D70-21
• Device Lot Number: 95220UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/09/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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 C4000 ANALYZER, LN 02P24-40; ARCHITECT C4000 ANALYZER, LN 02P24-40; SERIAL # (B)(4); SERIAL # (B)(4)