MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number 03L82-41

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

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 account generated a falsely depressed architect glucose of 10 mg/dl on a sample that repeated 143 mg/dl on another analyzer.The sample was processed again on the original analyzer with architect glucose of 145 mg/dl.No specific patient information or impact to patient management was reported.

Manufacturer Narrative

Review of complaint activity determined there were no other complaints for likely cause lot 49673uq07.Tracking and trending report review for the architect glucose assay determined that there are no related adverse or non-statistical trends.Manufacturing release documents were reviewed and all specifications were met prior to release.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect glucose assay was identified.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Type of Device: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6637410
• MDR Text Key: 77457243
• Report Number: 1628664-2017-00256
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 03L82-41
• Device Lot Number: 49673UQ07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LIST (B)(4) SERIAL (B)(4)