MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATINE KINASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Catalog Number 08P42-77

Device Problem Low Test Results (2458)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

The customer observed a falsely decreased alinity c creatine kinase result for one patient.The following data was provided (customer¿s reference range is 30-200 u/l): initial result was >4267, auto-dilution result was 93 u/l.The sample was manually diluted, and the result was 40573 u/l.The sample was auto-diluted again, and the result was 41541 u/l.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Initial reporter - phone: (b)(6).All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation for a falsely decreased alinity c creatine kinase (ck) result 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.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.As part of the troubleshooting, the sample was retested multiple times on the same analyzer and acceptable results were produced.In addition, the customer reviewed the sample status and found a small transparent clump that could had been aspirated from within the sample.Device history record review did not identify any non-conformances or deviations with the likely cause lot number and complaint issue.Manufacturing documentation for the likely cause lot number was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity c creatine kinase (ck), lot number 18756un22, was identified.

• Brand Name: ALINITY C CREATINE KINASE REAGENT KIT
• Type of Device: NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
• 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: 15867182
• MDR Text Key: 307196752
• Report Number: 3002809144-2022-00413
• Device Sequence Number: 1
• Product Code: CGS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983070
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Catalogue Number: 08P42-77
• Device Lot Number: 18756UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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)(4).; ALNTY C PROCESSING MODU, 03R67-01, (B)(4).