MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CARBON DIOXIDE

Model Number	3L80-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2020
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.Section a patient information: no specific patient information was provided.
Event or Problem Description
The customer obtained falsely elevated architect co2 results for patient samples and controls.The customer indicated after using a kit for two hours the results shift high and when retested on an alternate analyzer generate lower results.The customer indicated 8 samples generated initial results around 40 mmol/l and when retested on an alternate method generated results around 20 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
A search of lot number 55411uq07 for other tickets similar to this issue found no other complaints.Tracking and trending review for the carbon dioxide reagent did not identify any related trends.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and adequately addresses the customer issue.Based on the investigation, no systemic issue or product deficiency was identified for the carbon dioxide reagent.

• Brand Name: CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9714447
• Report Number: 1628664-2020-00061
• Device Sequence Number: 2928078
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• 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
• Report Date (Section B): 02/26/2020

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: 08/31/2020
• Device Model Number: 3L80-31
• Device Catalogue Number: 03L80-21
• Device Lot Number: 55411UQ01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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, LIST 02P24-40.; ARCHITECT C4000, LIST 02P24-40.; SERIAL (B)(6).; SERIAL (B)(6).