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

Model Number	3L80-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 58505uq11.Trending review determined no trend identified for falsely depressed results for the product.Return testing was not completed as returns were not available.Maintenance of the non-abbott water quality system and re-establishing the required product water quality to the instrument corrected the results issue.Results were returned to expected levels.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.The device history record review identified no non-conformances or deviations related to the complaint issue.A review of the labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect carbon dioxide reagent, lot number 58505uq11 was identified.
Event or Problem Description
The customer reported a high anion gap for a patient while using the architect c4000 analyzer.The following data was provided (normal range anion gap: 11-16): sodium = current = 133 mmol/l / previous = 143 mmol/l.Potassium = current = 4.6 mmol/l / previous = 5.1 mmol/l.Chloride = current = 107 mmol/l / previous = 113 mmol/l.Bicarbonate (co2) = current = 17 mmol/l / previous = 23 mmol/l.Anion gap = current = 18 / previous = 12.The anion gap is calculated measurement from sodium, chloride and bicarbonate (co2).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: 11952066
• Report Number: 3002809144-2021-00356
• Device Sequence Number: 3965266
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• 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
• 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): 06/07/2021

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: 12/31/2021
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 58505UQ11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1