MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-31

Device Problem High Test Results (2457)

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

Event Date 09/05/2018

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 elevated patient result for architect carbon dioxide and when repeated was normal.The customer provided (b)(6): initial result 33 meq/l and same day repeat result 28 meq/l (account normal range 23-31meq/l).No impact to patient management reported.The account does not know specific patient information.

Manufacturer Narrative

The customer performed instrument troubleshooting since their quality control (qc) seemed to drift out of range before calibration expiration.After troubleshooting the qc performance improved, but the qc values again drifted upward when the co2 test count drop down to about 50.Further investigation of the customer issue included a review of associated complaints, a review for complaint trends, a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• 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: 7895185
• MDR Text Key: 120978420
• Report Number: 1628664-2018-01894
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 03L80-31
• Device Lot Number: 52780UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1