MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Model Number 04V5121

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

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

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

(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 total bilirubin result for one patient.The sample was sent out to be tested on other platforms.The following data was provided: (b)(6) 2022 sid (b)(6) total bilirubin = 0.68 mg/dl (expected value 0.2 to 1.2 mg/dl).Hitachi total bilirubin =0.32 mg/dl (expected value 0.2 to 1.2 mg/dl).Toshiba total bilirubin = 0.07 mg/dl (expected value 0.1 to 1.2 mg/dl).Beckman total bilirubin = 0.6 mg/dl (expected value 0.3 to 1.0 mg/dl).Patient¿s historical result: (b)(6) 2022 performed on beckman dxc: total bilirubin = 0.33 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for discrepant alinity c total bilirubin result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review, and labeling 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.Ticket search by lot indicates that the reagent lot performs as expected for this product.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 61609uq03 and the complaint issue.The overall performance of the alinity c total bilirubin assay was reviewed using field data from customers worldwide.The median population result for lot 61609uq03 is within the established baseline, indicating the reagent lot is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c total bilirubin assay for lot 61609uq03 was identified.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16221563
• MDR Text Key: 308761923
• Report Number: 3002809144-2023-00049
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K121985
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 04V5121
• Device Catalogue Number: 04V51-21
• Device Lot Number: 61609UQ03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE, AC97903; ALINITY C PROCESSING MODULE, AC97903