MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CARBON DIOXIDE

Model Number 3L80-21

Device Problem High Test Results (2457)

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

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier multiple = (b)(6).There was no additional patient information provided due to privacy issues.This issue was previously reported under mdr number 1415939-2020-00089 under an incorrect manufacturing site: (b)(4).A review of tickets found no other complaints similar to the current complaint for lot 56397uq12.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.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 the investigation, no systemic issue or deficiency of carbon dioxide (co2) reagent, lot 56397uq12 was identified.

Event Description

The customer reported falsely elevated bicarbonate (co2) results for the past month on patient samples on the architect analyzer.The customer provided two examples of results: on (b)(6) 2020 (b)(6) initial = 40mmol/l / retest twice =20mmol/l (normal range 22-29mmol/l).There was no reported impact to patient management.

• Brand Name: CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10417521
• MDR Text Key: 245926028
• Report Number: 3016438761-2020-00181
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 3L80-21
• Device Catalogue Number: 03L80-21
• Device Lot Number: 56397UQ12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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