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

Catalog Number 07P72-20

Device Problem Low Test Results (2458)

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

Event Date 08/19/2023

Event Type  malfunction  

Manufacturer Narrative

Completed information for section a1 patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed alinity c carbon dioxide results for multiple samples on both alinity instruments.The following data was provided: sid (b)(6): ac01391 result = 20, ac01428 result = 21, cobas result = 23.Sid (b)(6): ac01391 result = 20, ac01428 result = 19, cobas result = 23.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely depressed alinity c carbon dioxide results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A search for similar complaints by lot number found normal complaint activity.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 63528uq02 and the complaint issue.As part of troubleshooting, it was found that calibrator values were not configured correctly for calibrator lot 79811fd01.The customer reconfigured the calibrator with the correct values and the quality controls were within the expected ranges.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c carbon dioxide assay for lot 63528uq02 was identified.Section g1 has been updated to current contact information.

Event Description

The customer observed falsely depressed alinity c carbon dioxide results for multiple samples on both alinity instruments.The following data was provided: sid (b)(6) : ac01391 result = 20, ac01428 result = 21, cobas result = 23.Sid (b)(6) : ac01391 result = 20, ac01428 result = 19, cobas result = 23.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: 17709898
• MDR Text Key: 322935315
• Report Number: 3002809144-2023-00387
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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: 03/31/2024
• Device Catalogue Number: 07P72-20
• Device Lot Number: 63528UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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, AC01391; ALNTY C PROCESSING MODU, 03R67-01, AC01391; ALNTY C PROCESSING MODU, 03R67-01, AC01428; ALNTY C PROCESSING MODU, 03R67-01, AC01428