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 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely decreased hemoglobin results on the alinity hq, serial number (b)(6) , for two patients.The results were not reported out.The sample was repeated on another alinity hq, hq00503 with expected results.The following data from (b)(6) 2023 was provided: hq00501: sid (b)(6) hgb = 7.60.Sid (b)(6) hgb = 5.61.Hq00503: sid (b)(6) hgb = 12.8.Sid (b)(6) hgb = 9.81 no impact to patient management was reported.

Event Description

The customer observed falsely decreased hemoglobin results on the alinity hq, serial number (b)(6), for two patients.The results were not reported out.The sample was repeated on another alinity hq, (b)(6) with expected results.The following data from (b)(6) 2023 was provided: (b)(6): sid (b)(6) hgb = 7.60.Sid (b)(6) hgb = 5.61.(b)(6): sid (b)(6) hgb = 12.8.Sid (b)(6) hgb = 9.81 no impact to patient management was reported.

Manufacturer Narrative

The investigation included a review of product historical data, product labeling and tracking and trending for alinity hq processing module.A review was performed for any trends and all customer complaints received for this issue.The review of this data did not identify any trends or abnormal complaint activity.Return testing was not completed as returns were not available.A flow detection fault on waste tank 2 was determined and the waste tank 2 was replaced by field service, resolving the issue of falsely low results on the alinity hq, serial number (b)(6).A review of the product historical data did not find a product issue related to the complaint incident.A labeling was found to be adequate for the complaint issue.Based on the available information no product deficiency of the alinity hq processing module, list number 09p68, serial number (b)(6), was identified.The following sections have been corrected to reflect the current contact (b)(6).

• 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: 17959069
• MDR Text Key: 326015345
• Report Number: 2919069-2023-00042
• Device Sequence Number: 1
• Product Code: GRZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: 00380740138851
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/29/2023

1 Device was Involved in the Event

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: 10/02/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO, H-3; ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO, H-3