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 09/18/2023

Event Type  malfunction  

Event Description

The customer observed falsely decreased hemoglobin results generated on the alinity hq analyzer for one sample.The following results were provided: (b)(6) 2023, sid (b)(6), alinity hq initial result 7.9 g/dl, new sample hemoglobin result was 15.6 g/dl.(b)(6) 2023, sid (b)(6), repeat result of original sample on cell-dyn sapphire the next day 15.3 g/dl.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

Updated information in section g: contact office address 1, contact office city, contact office postal code, contact office country, contact office first and last name, contact office email, contact office phone number, contact office fax number the field service engineer (fse) inspected the alinity hq analyzer and replaced staging tubing for rbc line, small check valves for the wbc line tubing, the staging pump and small check valves, and waste tubing from optics.A leaking fitting causing a pressure/vacuum leak was replaced.A review of tracking and trending did not identify any trends associated with the complaint issue.Labeling was reviewed and found to be adequate.The flow cytometry standard (fcs) files and the initial result printout from the alinity hq and the repeat result printout from the cell-dyn sapphire were provided by the customer for specimen id (sid) (b)(6).Review of the fcs files determined no algorithm issue was found.Review of the printouts and complaint notes confirmed the result observed by the customer.Based on the investigation, no systemic issue or deficiency of the alinity hq analyzer, sn (b)(6)was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely decreased hemoglobin results generated on the alinity hq analyzer for one sample.The following results were provided: (b)(6)2023 sid (b)(6)alinity hq initial result 7.9 g/dl, new sample hemoglobin result was 15.6 g/dl (b)(6)2023 sid (b)(6)repeat result of original sample on cell-dyn sapphire the next day 15.3 g/dl 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 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17818571
• MDR Text Key: 324275757
• Report Number: 2919069-2023-00029
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 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: 12/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1