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 12/15/2023

Event Type  malfunction  

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.

Event Description

The customer observed falsely decreased hemoglobin (hgb) patient results on the alinity hq processing module.The samples retested higher on a different module.One example was provided.(b)(6)2023 female patient who had ectopic pregnancy alinity hq hgb result of 73 g/l was reported out of the lab and questioned by the ward.Repeat testing generated a hgb result of 123 g/l.A new sample was drawn and the hgb result was 128 g/l.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument.The fsr found heavy crystallization around hgb reagent supply valves (125 &126), and replaced valves and fittings.The hgb cradle 1 was also noted to be crystalized; however, it was not determined to have impacted hgb results.Trending review did not identify any trends.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: 18465278
• MDR Text Key: 332374242
• Report Number: 2919069-2024-00003
• Device Sequence Number: 1
• Product Code: GRZ
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female