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 02/26/2024

Event Type  malfunction  

Event Description

The customer observed discrepant results generated from alinity c processing module for one patient.The results provided were: on(b)(6)2024 sid (b)(6)co2 initial=22.5 mmol/l /repeated=22.3, 21.8 and 19.3 mmol/l /send to reference lab from second specimen=19.0 mmol/l potassium initial=8.07, 6.76 and 5.26 mmol/l /repeated=4.93, 4.91 and 4.92 mmol/l /send to reference lab from second specimen=4.1 mmol/l total bilirubin=16.3 umol/l /repeated=16.9 umol/l /send to reference lab from second specimen=21.0 umol/l there was no reported impact to patient management.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for alinity c carbon dioxide reagent lot number 65006uq10.The ticket search determined that there is as expected complaint activity for the likely cause lot.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Historical performance of the alinity c carbon dioxide reagents in the field was reviewed using data gathered via abbottlink 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 65006uq10 is within the established control limits.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity c carbon dioxide reagent, lot number 65006uq10.

• 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: 18942718
• MDR Text Key: 338185310
• Report Number: 3002809144-2024-00079
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 380740121594
• UDI-Public: (01)380740121594(17)241130(10)65006UQ10
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/24/2024

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 Catalogue Number: 07P72-20
• Device Lot Number: 65006UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1