MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY HQ PROCESSING MODULE; COUNTER, DIFFERENTIAL CELL

Catalog Number 09P68-01

Device Problem Low Test Results (2458)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

A1 patient identifier: complete sample id's are (b)(6).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.

Event Description

The customer reported falsely low white blood cells generated from an alinity hq processing module and provided the following results.On (b)(6) 2023, sample id (b)(6) initial neutrophil count was 0.12 10e3/ul and repeat result was 4.73 10e3/ul on (b)(6) 2023, sample id (b)(6) initial wbc was 0.764 10e3/ul, repeat test was 4.12 10e3/ul.Additionally, the initial neutrophil count was 0.01 10e3/ul and repeat result was 1.75 10e3/ul.Per the customer no discrepant results were reported to the patient¿s medical provider.There was no reported impact to patient management.

Manufacturer Narrative

The alinity hq processing module serial number (b)(6) was inspected, and it was noted that multiple various tubing, valves, and check valves in areas of the injection manifold and staging pump required replacement, and cleaning of the analyzer was performed.Quality control runs were then reportedly ok.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.A review of ticket tracking and trending did not identify a trend for the alinity hq processing module, nor was an increase in complaint activity found.A review of the manufacturing documentation did not identify any product issues.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity hq processing module serial number (b)(6).

Event Description

The customer reported falsely low white blood cells generated from an alinity hq processing module and provided the following results.On (b)(6) 2023, sample id (b)(6) initial neutrophil count was 0.12 10e3/ul and repeat result was 4.73 10e3/ul.On (b)(6) 2023, sample id (b)(6) initial wbc was 0.764 10e3/ul, repeat test was 4.12 10e3/ul.Additionally, the initial neutrophil count was 0.01 10e3/ul and repeat result was 1.75 10e3/ul.Per the customer no discrepant results were reported to the patient¿s medical provider.There was no reported impact to patient management.

• Brand Name: ALINITY HQ PROCESSING MODULE
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 17926964
• MDR Text Key: 325593086
• Report Number: 2919069-2023-00037
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 00380740138851
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K220031
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09P68-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1