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

Model Number	3L80-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10417521
• Report Number: 3016438761-2020-00181
• Device Sequence Number: 11365231
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1