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

Model Number 3L80-22

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 304783332
• Report Number: 3002809144-2022-00273
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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).