MAUDE Adverse Event Report: ABBOTT GMBH CARBON DIOXIDE; ENZYMATIC, CARBON-DIOXIDE

Model Number	3L80-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.The complaint investigation was performed for observed false elevated carbon dioxide results which included a search for similar complaints, and review of the complaint text, trending data, labeling, device history records, and historical performance of reagent lot 58854uq01 through worldwide data.A review of tickets determined there is normal complaint activity for lot number 58854uq01.Trending review determined no trends identified for the product related to the issue.Return testing was not completed as returns were not available.Historical performance was reviewed using worldwide data and determined that the patient median result for carbon dioxide reagent lot number 58854uq01 is within established control limits.The device history record was reviewed and determined no non-conformances or deviations related to the complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of carbon dioxide reagent lot number 58854uq01 was identified.
Event or Problem Description
The customer observed falsely elevated carbon dioxide (co2) results for 8 patients while running on the architect c4000 analyzer.The customer investigated further after discovering high patient co2 results and decided to run qc to verify that the controls were still in range even though the daily qc was performed and in range for that morning.The qc generated values out of range on all three levels of control.The customer removed the old pack with 18 tests left and loaded a new reagent kit of the same lot number and calibrated the kit on the analyzer.The customer ran qc and it was in range for the new reagent kit.The samples were then repeated on the same analyzer with the following data provided (customer¿s normal range: 18-30 mmol/l): sid (b)(6) = initial = 33 mmol/l, repeat = 24 mmol/l.Sid (b)(6) = initial = 39 mmol/l, repeat = 31 mmol/l.Sid (b)(6) = initial = 43 mmol/l, repeat = 30 mmol/l.Sid (b)(6) = initial = 36 mmol/l, repeat = 25 mmol/l.Sid (b)(6) = initial = 39 mmol/l, repeat = 26 mmol/l.Sid (b)(6) = initial = 35 mmol/l, repeat = 24 mmol/l.Sid (b)(6) = initial = 34 mmol/l, repeat = 21 mmol/l.Sid (b)(6) = initial = 41 mmol/l, repeat = 24 mmol/l.There was no impact to patient management reported.

• Brand Name: CARBON DIOXIDE
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12332539
• Report Number: 3002809144-2021-00490
• Device Sequence Number: 4441731
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: 02/28/2022
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 58854UQ01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1