MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE

Catalog Number 07P72-20

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Correction/removal reporting number = 3002809144-10/24/19-009-r the investigation into this matter found that the amount of co2 absorbed was higher with increased reagent carousel rotation and when the volume of the reagent in the cartridge is reduced.This phenomenon could be detected as a shift in qc and also incorrect patient results.A product recall letter was sent to all customers who have received shipments of the impacted lots of the alinity c carbon dioxide reagent kit.The letter instructs the following: immediately discontinue use of the alinity c carbon dioxide 15000t kit and destroy any remaining inventory as existing modes of control are not effective for the large cartridge.Run two levels of co2 controls every hour with the use of the current alinity c carbon dioxide 3000t kit, instead of every 24 hours, and perform assay calibration as needed to minimize the potential to generate incorrect results.All current inventory of alinity c carbon dioxide (ln 07p7220), will be reworked to include a kit stuffer instructing customers to run qc every hour.In future lots of the alinity c carbon dioxide 3000t kit, the reagent cartridge fill volume will be increased from 12.7 ml to 20.7 ml, which has been confirmed to minimize co2 absorption.

Event Description

The customer reported imprecision in the quality controls (qc) while using the carbon dioxide (co2) reagent.The customer was instructed to run 3-4 runs of duplicate qcs per day.The customer stated the 3 level qc materials were all tested on the same reagent cartridge with the same calibration curve.There was no reported impact to patient management.

Manufacturer Narrative

Complete information for section h9.Correction/removal reporting number = 3002809144-10/24/19-009-r upon further review, the customer's issue is not associated with remedial action 3002809144-10/24/19-009-r and is unassigned from the field action.

• Brand Name: ALINITY C CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9512911
• MDR Text Key: 219779863
• Report Number: 3002809144-2019-01086
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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: 10/31/2020
• Device Catalogue Number: 07P72-20
• Device Lot Number: 55731UQ09
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002809144-10/24/19-009-
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE; ALINITY C PROCESSING MODULE; LIST 03R67-01, SN (B)(4); LIST 03R67-01, SN (B)(4)