MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number 03L82-21

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and labeling review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.

Event Description

The customer observed discrepant falsely low glucose results generated using the clinical chemistry glucose reagents.The following data was provided and was generated in (b)(6) 2016.Initial 0.19 g/l (19 mg/dl); repeat 1.75 g/l (175 mg/dl); repeated as part of reproducibility, 10 replicates ranged from 1.26 to 1.87 g/l (126 to 187 mg/dl).No impact to patient management was reported.

• 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: 6559117
• MDR Text Key: 74991662
• Report Number: 1628664-2017-00204
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 03L82-21
• Device Lot Number: 48341UQ09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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: ARCHITECT C8000 ANALYZER; LIST NUMBER 01G06-01; SERIAL NUMBER (B)(4)