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 Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier of multiple is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account observed falsely elevated architect magnesium on 2 patient samples that repeated lower.(b)(6) was 3.03 but repeated 1.3 mg/dl.(b)(6) was 2.79 but repeated 1.3 mg/dl.The account uses a normal range of 1.6 to 2.6 mg/dl.No impact to patient management was reported.No specific patient information was provided.
Additional Manufacturer Narrative
The customer observed the issue when the reagent cartridge contained less than 50 tests.A review of the complaint handling database finds no atypical complaint trends for the magnesium assay identified.In addition, there are other tickets for the same or similar issues, however individual investigations of these have not identified a quality issue to date.The customer's architect system instrument logs were reviewed.The higher than expected magnesium patient results were observed.The higher results were the last tests aspirated from the magnesium reagent cartridge serial number 03164 in use.Another cartridge, serial number (b)(4) from lot 99662un18, results were also identified in the instrument logs.213 results were reviewed and an elevated rate of higher than expected results were not identified for this cartridge of the same lot.Based on this information, it appears the magnesium reagent lot 99662un18 cartridge serial number (b)(4) may have been compromised or contaminated.However, when considering magnesium reagent lot 99662un18, cartridge serial number (b)(4), and the complaint trends to date, it appears the reagent is performing as expected in the field.Use error may have contributed to the customer's issue as possible contamination of the reagent during use.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency 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: 7836030
• Report Number: 1628664-2018-01717
• Device Sequence Number: 1338027
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 04/13/2020
• Device Catalogue Number: 07D70-31
• Device Lot Number: 99662UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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 C16000 LIST 03L77-01; ARCHITECT C16000 LIST 03L77-01, (B)(4); SERIAL (B)(4)