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 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

A1 - patient identifier: (b)(6) and (b)(6) (same patient different blood collections) 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 decreased platelet results for one patient hospitalized for anemia while running on the alinity hq processing module.The following data was provided: (b)(6) 2023: (b)(6) (b)(6) 2023: (b)(6) the patient was tested at a different facility and generated a platelet count between (b)(6) cells/ul (b)(6).A microscope examination was performed by the customer, however the results were not provided.There was no impact to patient management reported.

Event Description

The customer reported falsely decreased platelet results for one patient hospitalized for anemia while running on the alinity hq processing module.The following data was provided: on (b)(6) 2023: sid (b)(6): platelet results = 24.90, 16.80, and 11.10 10e9/l.On (b)(6) 2023: sid (b)(6): platelet results = 22.20, 21.30, and 26.00 10e9/l.The patient was tested at a different facility and generated a platelet count between 50000 to 60000 cells/ul (50 to 60 10e9/l).A microscope examination was performed by the customer, however the results were not provided.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and review of manufacturing documentation.Return testing was not completed as returns were not available.No increase in complaint activity was identified for alinity hq processing module.A review of tracking and trending for the alinity hq processing module did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Flow cytometry standard (fcs) files and result printouts from the alinity hq processing module were reviewed; however, the result printout did not contain the plt results at issue, and the fcs files did not correlate to the plt results documented in the complaint.No further information could be obtained.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the alinity hq processing module for serial (b)(6) was identified.

• 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: 17996595
• MDR Text Key: 327257966
• Report Number: 2919069-2023-00044
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 00380740138851
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1