MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) ACCELERATOR APS ALIQUOTER MODULE

Catalog Number 07L40-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

Udi (b)(4).Correction/removal number: 3016438761-04/06/20-001-c.A product correction letter has been issued to all worldwide customers with installed accelerator aps aliquoter module.The letter informs the customer of the potential reliability issue with the contamination of the primary tube with water from the aliquoter module hydraulic circuit which could lead to incorrect results.The letter instructs the customer to discard the primary tube flagged with clot detection error or manage it according to laboratory guidelines considering that it may be diluted, and to call customer support in case the frequency of the clot detection error increases (more than 5 consecutive clot detection errors).

Event Description

Abbott has identified the potential risk of contamination of the primary tube with water from the aliquoter module hydraulic circuit, which could lead to incorrect results.The aps aliquoters current error recovery procedure dispenses the aliquoter volume back into the primary tube in the case of an aqm clot detection error (error code e0e0).If the error is not due to a sample clot, but generated from an aliquoter hardware failure, a portion of the distilled water from the aliquoter module hydraulic circuit may be dispensed into the primary tube leading to sample dilution.This issue can occur when a hardware error creates the clot detection error.There has been no reported patient harm due to this issue.

• Brand Name: ACCELERATOR APS ALIQUOTER MODULE
• Type of Device: ALIQUOTER MODULE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9967415
• MDR Text Key: 225480866
• Report Number: 3016438761-2020-00023
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/16/2020

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: 07L40-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3016438761-04/06/20-001
• Patient Sequence Number: 1