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  

Event Description

The customer reported falsely decreased alinity c co2 results for 2 patient samples while running on multiple alinity c processing modules.The following co2 results were provided:(b)(6): alinity ac01428 = 21 mmol/l; alinity ac1391 = 20 mmol/l; cobas = 23 mmol/l.(b)(6): alinity ac1428 = 19 and 19 mmol/l; alinity ac1391 = 20 mmol/l; cobas = 23 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

E1 - postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.A1 - patient identifier: (b)(6) (2 patients).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the alinity c co2 reagents in the field was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 63528uq02 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c co2 reagent lot 63528uq02 was identified.Corrected information in section: g1 contact name, contact office address, contact office email, contact office phone number.

Event Description

The customer reported falsely decreased alinity c co2 results for 2 patient samples while running on multiple alinity c processing modules.The following co2 results were provided: (b)(6): alinity (b)(6)= 21 mmol/l; alinity (b)(6) = 20 mmol/l; cobas = 23 mmol/l (b)(6): alinity (b)(6) = 19 and 19 mmol/l; alinity ac1391 = 20 mmol/l; cobas = 23 mmol/l there was no impact to patient management 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: 17638157
• MDR Text Key: 322804220
• Report Number: 3002809144-2023-00372
• 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: 11/29/2023

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: 08/28/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/29/2023
• 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, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)