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

Catalog Number 09P68-01

Device Problem High Test Results (2457)

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

Event Date 01/15/2024

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 a falsely elevated hemoglobin result on the alinity hq, serial number (b)(6) for one 3 year-old patient.The customer states sample was a pediatric tube that did not appear to be mixed properly.The following data was provided: initial result = 225 g/l repeat 73 g/l.Lab range = hgb 105 - 135 g/l.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for discrepant results generated on the alinity hq processing module, serial number (b)(6), included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review 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 sufficiently addresses the customer's issue.Field service inspected the instrument for mixing issues and none were found.Multiple samples were run and no issues were observed with the resuspension unit.Inspection of the pediatric tubes found they were completely full of blood and there was no space in the tubes to allow for sufficient mixing of the sample.The customer agreed that there was no issue with the analyzer and follow-up would be performed by the lab staff with their phlebotomist.Based on the information provided, a product deficiency was not identified.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications or otherwise performed as intended at the customer site.Use error contributed to this event as the pediatric tubes used were completely full with blood, and no space in the tubes was present to allow for sufficient mixing of the samples.

Event Description

The customer observed a falsely elevated hemoglobin result on the alinity hq, serial number (b)(6) for one 3 year-old patient.The customer states sample was a pediatric tube that did not appear to be mixed properly.The following data was provided: initial result = 225 g/l repeat 73 g/l lab range = hgb 105 - 135 g/l no impact to patient management was reported.

• 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: 18554693
• MDR Text Key: 333388896
• Report Number: 2919069-2024-00009
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR