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 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated architect glucose result fo a (b)(6) year old male patient.Sample id (b)(6) generated 19.91 mmol/l (358.74 mg/dl) and retest of 4.82 mmol/l (86.45 mg/dl).No impact to patient management was reported.

Manufacturer Narrative

Investigation of the issue included a review of the complaint text, a search for similar complaints, review of manufacturing documentation and labeling.Return testing was not completed as returns were not available.The customer analyzed the data and discovered their non-abbott ckmb resgent had interfered with the glucose assay as the ckmb reagent contained glucose.The customer adjusted the position of the two assays and subsequent testing was acceptable.Review of complaint activity found no other complaints for reagent lot 54493uq01.Tracking and trending report review for the architect glucose assay determined that there were no related trends.Manufacturing documentation including the certificate of analysis for the reagent lot was reviewed.This review found the lot was released within specifications and all abbott acceptance requirements were met.No issues were identified associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect glucose assay was identified.

• Brand Name: GLUCOSE
• Type of Device: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9166317
• MDR Text Key: 192387512
• Report Number: 1628664-2019-00656
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 03L82-21
• Device Lot Number: 54493UQ01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 ANALYZER; ARCHITECT C16000 ANALYZER; LIST 03L77-01, SERIAL (B)(4); LIST 03L77-01, SERIAL (B)(4)
• Patient Age: 30 YR