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	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a shift down in co2 (carbon dioxide) results generated on the architect c4000 instrument after changing the calibrator lot when compared to the blood gas co2 results.Patient 1 architect co2 result was 19 mmol/l, blood gas result was 28.7 mmol/l, (reference range 22 mmol/l to 29 mmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, and device history record review.Return testing was not completed as returns were not available.A review of tickets determined that there is normal complaint activity for the complaint lot.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with the complaint lot and the complaint issue.Labeling is adequate and provides specific instructions to the customer regarding the current issue.The customer recalibrated the same reagent (new kit), however got the same calibration profile and control values on both modules.Maintenance and troubleshooting was performed.The issue appears to be sample specific for certain patient samples and/or handling of calibrator.Quality controls remain within range at the time of the incident.Based on the investigation, no systemic issue or deficiency was identified.Section d10.Concomitant product- additional product added cc co2 cal(6x5ml), 01e64-03, 98513fd01 manufacture date 12/23/2020, and expiration date 12/15/2021.

• 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: 11895206
• Report Number: 3002809144-2021-00339
• Device Sequence Number: 16491310
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 11/30/2021
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 58158UQ10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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 C4000 INTGR, 02P24-40, C401506; ARC C4000 INTGR, 02P24-40, C401506; CC CO2 CAL(6X5ML), 01E64-03, 98513FD01