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	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6) ( 3 patients).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely decreased carbon dioxide (co2) results for approximately 50 patient samples while running on the architect c8000 processing module.When the customer calibrated the co2 assay, the qc was out-of-range-low.The customer recalibrated with new calibration vials and opened new qc.The customer stated the controls were acceptable and started running patient samples.Customer believes about 50 patients results are lower than the reference range and the previous results were in range.The customer confirmed no discrepant results were reported to the clinician.The following are examples of patient results that were provided by the customer: patient examples: sid (b)(6): result 21 meq/l, previous results 25/28 meq/l sid (b)(6): result 21 meq/l, previous results 23/26/25 meq/l sid (b)(6): result 19 meq/l, previous result 23 meq/l customer's reference range: 22-29 meq/l there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed co2 results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A search of complaints by lot number determined normal complaint activity.The tracking and trending were reviewed by the product list number and found no trends related to this issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Review of the device history records did not identify any nonconformances or deviations associated with current complaint.Labeling was reviewed and found to adequately address the issue under review.As part of troubleshooting, customer recalibrated assay and calibrated sample and r1 probes which resolved issue.No additional issues were identified; no further action is required.Based on the investigation, no systemic issue or product deficiency was identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• Brand Name: CARBON DIOXIDE
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15179965
• Report Number: 3002809144-2022-00273
• Device Sequence Number: 6269585
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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 Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 61634UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC C8 PROC MOD, 01G06-11, (B)(6).; ARC C8 PROC MOD, 01G06-11,(B)(6).; CC CO2 CAL(6X5ML), 01E64-03, (B)(6).; CC CO2 CAL(6X5ML), 01E64-03, (B)(6).
• Patient Sex: Unknown