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 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed platelet results generated on the alinity hq processing module.The customer stated that since updating to version 5.0 software, the alinity hq processing module has had a problem reading macro platelets and platelet aggregates.The following data was provided: sid (b)(6) plt result instrument: 11.6, manual platelet count 63.No impact to patient management was reported.

Manufacturer Narrative

Scatterplot images and manual results for plt were submitted by the customer.The baso results presented in this ticket were all within the typical normal range.The shift of baso could not be characterized by the data presented.Rdw baseline was not provided so rdw shift could not be determined.The plt results in the table showed discrepancies in plt results between the alinity hq and manual count.The review of the smears did not identify any plt clumps nor any large plts.Rbcs appeared flat without typical biconcave shape.Target cells were spotted.A review of all complaints associated with the alinity hq (list number 09p68-01) and a review of complaint trends for the list number was performed.The review did not identify any trends or abnormal complaint activity.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no deficiency 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: 18607846
• MDR Text Key: 334497148
• Report Number: 2919069-2024-00012
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 00380740138851
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1