MAUDE Adverse Event Report: ABBOTT LABORATORIES 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).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided due to privacy issues.
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.
Additional Manufacturer Narrative
After further evaluation, this submission was filed on the incorrect manufacturing site in section d and section g 1.2.Manufacturing site for devices - abbott laboratories, 100 abbott park road, abbott park, il 60064-3500, usa.A new submission mdr number 3016438761-2020-00181 has been submitted and all further information will be documented under that mdr number.

• Brand Name: CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 10276595
• Report Number: 1415939-2020-00089
• Device Sequence Number: 17015234
• 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,Followup
• 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
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement 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
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C8000 SYSTEM, LN 01G06-11,; ARCHITECT C8000 SYSTEM, LN 01G06-11,; SERIAL # (B)(6); SERIAL # (B)(6)