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 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11895206
• MDR Text Key: 272725254
• Report Number: 3002809144-2021-00339
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C401506; ARC C4000 INTGR, 02P24-40, C401506; CC CO2 CAL(6X5ML), 01E64-03, 98513FD01