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 02/07/2024

Event Type  malfunction  

Event Description

The customer observed falsely decreased cbc (complete blood count) results generated from alinity hq processing module for one patient.The results provided were: initial results from alinity hq00417 /repeated on alinity hq00416 wbc initial=2.41 /repeated=5.65; rbc initial=3.06 /repeated=5.38; hemoglobin initial=7.92 g/dl /repeated=15.3 g/dl; platelet initial=178 /repeated=269 there was no reported impact to patient management.

Manufacturer Narrative

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 observed falsely decreased cbc (complete blood count) results generated from alinity hq processing module for one patient.The results provided were: initial results from alinity hq00417 /repeated on alinity hq00416 wbc initial=2.41 /repeated=5.65; rbc initial=3.06 /repeated=5.38; hemoglobin initial=7.92 g/dl /repeated=15.3 g/dl; platelet initial=178 /repeated=269 there was no reported impact to patient management.

Manufacturer Narrative

The field service representative (fsr) inspected the replaced of valve-check, inline, ppro (list number (b)(6) which resolved the issue.Review of the data found that the neu, lym, mono, eos, and ig parameters were flagged as invalid and boundary not found flags were generated for seq 305359.The review did not identify any adverse trends or abnormal complaint activity.Additionally, labeling was reviewed and adequately addressed the issue under review.Return testing was not completed as returns were not available.A review of the product historical data did not find a product issue related to the complaint incident.Based on the available information no product deficiency of the alinity hq processing module, list number 09p68, serial number (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: 18712246
• MDR Text Key: 336052918
• Report Number: 2919069-2024-00017
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1