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	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.
Event or Problem Description
The customer reported false elevated architect co2 assay results for three patients.The customer provided: (b)(6) initial = >50 mmol/l, repeat = 27 mmol/l; (b)(6) initial = >50 mmol/l, repeat = 24 mmol/l; (b)(6) initial = >50 mmol/l, repeat 20.3, 20.4 mmol/l (range: 23.0 to 31 mmol/l).There was no impact to patient management reported.
Additional Manufacturer Narrative
The evaluation of the customers issue included a review of tickets determined that there is normal complaint activity for lot 56991uq02.Trending review determined no trend for falsely elevated results ln 03l80-22.Return testing was not completed as returns were not available.Qc results were within range during the time of this occurrence.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 all available information, no product deficiency was identified.
Additional Manufacturer Narrative
On 08sep2020 it was discovered that this submission was filed on the incorrect manufacturing site in section d 3 and section g 1.2.A new emdr, number 3016438761-2020-00206, 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: 10365161
• Report Number: 1415939-2020-00117
• Device Sequence Number: 951185
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2020

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: 03/31/2021
• Device Model Number: 3L80-21
• Device Catalogue Number: 03L80-22
• Device Lot Number: 56991UQ02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 09/08/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/04/2020; 09/10/2020
• 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 C4000 SYSTEM,; ARCHITECT C4000 SYSTEM,; ARCHITECT C4000 SYSTEM,; LN 02P24-40, SN (B)(4); LN 02P24-40, SN (B)(6); LN 02P24-40, SN (B)(6)