MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC 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	01/07/2020
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.There was no further patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated co2 results for 7 patients generated on the architect analyzer.The results provided were: on (b)(6) 2020 sid (b)(6) = 29 / 32 / 33; sid (b)(6) = 23 / 36meq/l (normal range 22-29meq/l).On (b)(6) 2020 additional results provided: sid (b)(6) = 33 /22; sid (b)(6) = 30 /25; sid (b)(6) = 33 / 22; sid (b)(6) = 33 /25; and sid (b)(6) = 33 / 22.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets found no other complaints for lot 55411uq07, and no trends were identified for the issue.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 product deficiency was identified for the clin chem co2 reagent, lot 55411uq07.

• Brand Name: CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9638791
• Report Number: 1628664-2020-00034
• Device Sequence Number: 11493640
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• 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): 02/19/2020

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: 3L80-21
• Device Catalogue Number: 03L80-21
• Device Lot Number: 55411UQ07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/19/2020
• 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 01G06-01,; ARCHITECT C8000 SYSTEM, LN 01G06-01,; SERIAL # (B)(4); SERIAL # (B)(4)