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 02/15/2024

Event Type  malfunction  

Event Description

The customer observed a falsely decreased neutrophil result generated on the alinity hq processing module for a patient sample.The following data was provided: on initial run, neuts are incorrectly counted as eos.No flags or invalid data warning given.Sample id (b)(6): (b)(6) 2024 neut initial result = 0.003 10e9/l 16feb2024 neut repeat result = 1.44 10e9/l, repeat result on another analyzer hq01143 = 1.49 10e9/l.Additional data provided: (b)(6) 2024: wbc initial result = 4.42 10e9/l; hgb initial result = 126 g/l; plt initial result = 250 10e9/l.(b)(6) 2024: wbc repeat result = 4.25 10e9/l, repeat result on another analyzer hq01143 = 4.28 10e9/l hgb repeat result = 127 g/l, repeat result on another analyzer hq01143 = 124 g/l plt repeat result = 248 10e9/l, repeat result on another analyzer hq01143 = 241 10e9/l no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a falsely decreased neutrophil result generated on the alinity hq processing module for a patient sample.The following data was provided: on initial run, neuts are incorrectly counted as eos.No flags or invalid data warning given.Sample id (b)(6).On (b)(6) 2024 neut initial result = 0.003 10e9/l.On (b)(6) 2024 neut repeat result = 1.44 10e9/l, repeat result on another analyzer (b)(6) = 1.49 10e9/l.Additional data provided: 15feb2024 wbc initial result = 4.42 10e9/l.Hgb initial result = 126 g/l.Plt initial result = 250 10e9/l.(b)(6) (b)(6) 2024.Wbc repeat result = 4.25 10e9/l, repeat result on another analyzer (b)(6) = 4.28 10e9/l.Hgb repeat result = 127 g/l, repeat result on another analyzer (b)(6) = 124 g/l.Plt repeat result = 248 10e9/l, repeat result on another analyzer (b)(6) = 241 10e9/l.No impact to patient management was reported.

Manufacturer Narrative

Update: section h4 - device mfg date - updated from blank to 11/22/2022 section d4 - primary udi number: this section was corrected from (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and manufacturing record 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 without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity.A review of tracking and trending did not identify any trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the alinity hq processing module for serial hq01145 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: 18902177
• MDR Text Key: 337756727
• Report Number: 2919069-2024-00023
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 00380740138851
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1