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 10/13/2023

Event Type  malfunction  

Event Description

The customer observed falsely depressed wbc results generated on the alinity hq processing module (hq00939) for one sample.The following data was provided: sid 022823101330: hq00939 result = 8.96 k/ul, hq00926 result = 51.9 k/ul additional laboratory data was provided: hq00939 generated data invalidating flags for neutrophils, lymphocytes, eosinophils, basophils, and ig differential results.The discrepant results were not reported out of the laboratory.No impact to patient management was reported.

Manufacturer Narrative

Completed information for section a1 patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed wbc results generated on the alinity hq processing module ((b)(6)) for one sample.The following data was provided: sid (b)(6): (b)(6) result = 8.96 k/ul, (b)(6) result = 51.9 k/ul additional laboratory data was provided: (b)(6) generated data invalidating flags for neutrophils, lymphocytes, eosinophils, basophils, and ig differential results.The discrepant results were not reported out of the laboratory.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) checked optics for leakage.S1 and s2 tubings from nozzle to injection manifold were replaced, as well as tubing from the injection manifold to the wbc and rbc staging pumps.Check valves for bubble mixing in both wbc cups and tubing in drain pinch valves were replaced.The check valve after v09 and after the waste asp/disp chamber were proactively replaced.Replacement of valves v55 and v57 in the sampling switching manifold is what resolved the issue.Return testing was not completed as returns were not available.A review of customer data aligned with the customer¿s issue and no additional issues were identified.An instrument service history review revealed no additional erratic or discrepant patient results reported for (b)(4).There were no service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A search for similar complaints did not identify an increase in complaint activity.A review of tracking and trending for the assy, valve, lvm09, 2/2 n.C., 24vdc did not identify any trends.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 (b)(6) or the assy, valve, lvm09, 2/2 n.C., 24vdc 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: 17985443
• MDR Text Key: 326293411
• Report Number: 2919069-2023-00043
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 00380740138851
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1