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

Model Number	3L80-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided.
Event or Problem Description
The customer observed falsely decreased co2 results on the architect c4000 analyzer for two pregnant patients.On (b)(6) 2020 sid (b)(6) result 14 meq/l.On (b)(6) 2020 sid (b)(6) result 15 meq/l.The customer's normal range is 22 - 32 meq/l.Values less than 16 meq/l are considered critical.Both patients had normal arterial blood gas co2 values (21 - 23 meq/l).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 56332uq12.Trending review determined no adverse trend for falsely depressed results for the product.Return testing was not completed as returns were not available.The issue appears to be sample specific for certain patient samples.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 the investigation, no systemic issue or deficiency of carbon dioxide (co2) reagent (ln 3l80-22) lot 56332uq12 was identified.

• 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: 10296192
• Report Number: 3016438761-2020-00132
• Device Sequence Number: 11416235
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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): 08/13/2020

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: 56332UQ12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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 ANALYZER, LIST 02P24-40; ARCHITECT C4000 ANALYZER, LIST 02P24-40; SERIAL (B)(6); SERIAL (B)(6)