MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT HEMOGLOBIN A1C; HEMOGLOBIN A1C CALIBRATORS

Catalog Number 04P52-01

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation into this issue determined that there is a high possibility that control and calibrator materials had been mixed during the fill process and that hba1c calibrator lot 54582uq02 may contain a quantity of high control material instead of calibrator level 2 (l2).A product recall letter was issued to all architect customers who have received the architect hba1c calibrator lot 54582uq02.This lot may generate an active calibration curve, a shift to qc and patient results may occur.The letter instructs.

Event Description

The customer reported a calibration failure while using the architect hba1c calibrator lot 54582uq02.There was no report of incorrect patient results or impact to patient management.

• Brand Name: ARCHITECT HEMOGLOBIN A1C
• Type of Device: HEMOGLOBIN A1C CALIBRATORS
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8785830
• MDR Text Key: 150864564
• Report Number: 1628664-2019-00495
• Device Sequence Number: 1
• Product Code: JIT
• UDI-Device Identifier: 00380740102722
• UDI-Public: 00380740102722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2020
• Device Catalogue Number: 04P52-01
• Device Lot Number: 54582UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-05/30/19-005-R
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000, LIST 01G06-11; SERIAL (B)(4)