MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Catalog Number 07P72-20

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

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

Event Date 10/28/2023

Event Type  malfunction  

Manufacturer Narrative

Section a1 - patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepant alinity c carbon dioxide results generated on the alinity c processing module for multiple patient samples.The customer stated some samples generated the alinity c carbon dioxide results of around 37 mmol/l and when repeated on another instrument, the results were within the normal range of 22 to 30 mmol/l.Additionally, some patient samples generated falsely decreased alinity c carbon dioxide which were discrepant with the blood gas results.The following data was provided: (b)(6) 2023 sid (b)(6) alinity result = 8.3 mmol/l; blood gas (venous) co2 result = 39 mmhg sid (b)(6) alinity result = 12.0 mmol/l; blood gas (venous) co2 result = 41 mmhg no impact to patient management was reported.

Manufacturer Narrative

Section d4 - lot #: updated from unknown to 63965uq04.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 63965uq04 and complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.The samples, when reran on another analyzer using same reagent lot, generated all results within normal range.Quality controls were in range during the time of discrepant results.The customer ran precision and performed calibration again after which no further discrepant results were seen.Based on this investigation, no systemic issue or deficiency was identified with the alinity c carbon dioxide reagent, lot number 63965uq04.

Event Description

The customer observed discrepant alinity c carbon dioxide results generated on the alinity c processing module for multiple patient samples.The customer stated some samples generated the alinity c carbon dioxide results of around 37 mmol/l and when repeated on another instrument, the results were within the normal range of 22 to 30 mmol/l.Additionally, some patient samples generated falsely decreased alinity c carbon dioxide which were discrepant with the blood gas results.The following data was provided: 28oct2023 sid (b)(6) alinity result = 8.3 mmol/l; blood gas (venous) co2 result = 39 mmhg.Sid (b)(6) alinity result = 12.0 mmol/l; blood gas (venous) co2 result = 41 mmhg.No impact to patient management was reported.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18159513
• MDR Text Key: 328398080
• Report Number: 3002809144-2023-00470
• Device Sequence Number: 1
• Product Code: KHS
• 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: 02/08/2024

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: 05/31/2024
• Device Catalogue Number: 07P72-20
• Device Lot Number: 63965UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)