MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I STAT CK-MB REAGENT KIT; FLUOROMETRIC METHOD, CPK OR ISOENZYMES

Catalog Number 04V38-20

Device Problem High Test Results (2457)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i stat ck-mb results for a 91-year-old female patient.The patient¿s previous result was 4.0 ng/ml (b)(6) 2023 6:56 sid (b)(6)= 79.40 ng/ml.(b)(6) 2023 7:52 sid (b)(6) = 20.88 ng/ml.(b)(6) 2023 8:10 sid (b)(6)= 21.63 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: (b)(6).Completed information for section e1 phone number : (b)(6).This report is being filed on an international product, list number 04v38-20 that has a similar product distributed in the us, list number 4v38-21 / 31.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity i stat ck-mb results 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 in-house testing.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review on lot 40028fn00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue.In-house accuracy testing was completed using an in-house retained kit of lot 40028fn00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the alinity i stat ck-mb assay for lot number 40028fn00 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated alinity i stat ck-mb results for a 91-year-old female patient.The patient¿s previous result was 4.0 ng/ml (b)(6) 2023 6:56 sid (b)(6) = 79.40 ng/ml.(b)(6) 2023 7:52 sid (b)(6) = 20.88 ng/ml.(b)(6) 2023 8:10 sid (b)(6) = 21.63 ng/ml.No impact to patient management was reported.

• Brand Name: ALINITY I STAT CK-MB REAGENT KIT
• Type of Device: FLUOROMETRIC METHOD, CPK OR ISOENZYMES
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17058229
• MDR Text Key: 316594579
• Report Number: 3008344661-2023-00099
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Catalogue Number: 04V38-20
• Device Lot Number: 40028FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)