MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC GLUCOSE

Catalog Number 03L82-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.

Event Description

The customer reported falsely elevated glucose results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2019 (b)(6) initial = 282.7mg/dl / repeated on (b)(6) 2019 = 92mg/dl / hba1c = 5.5; new sample on (b)(6) 2019 (b)(6)= 82.2mg/dl.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets for lot 54742uq04 did not find any additional complaints and no trends were identified for the product issue.Return testing was not completed as returns were not available.A review of the architect, serial number (b)(6), instrument logs did not find the data provided by the customer.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on our investigation no product deficiency was identified for the clin chem glucose, lot 54742uq04.

• Brand Name: GLUCOSE
• Type of Device: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9272840
• MDR Text Key: 219489384
• Report Number: 1628664-2019-00697
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 03L82-21
• Device Lot Number: 54742UQ04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER, LN 02P24-40,; ARCHITECT C4000 ANALYZER, LN 02P24-40,; SERIAL # (B)(6); SERIAL # (B)(6)