MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-31

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

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 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.

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
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7836030
• MDR Text Key: 118884612
• Report Number: 1628664-2018-01717
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (y/n): N
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 LIST 03L77-01; ARCHITECT C16000 LIST 03L77-01, (B)(4); SERIAL (B)(4)