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

Catalog Number 04P52-01

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2019

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 the customer to discontinue use of the suspected lots and destroy any remaining inventory.

Event Description

Abbott laboratories has identified an issue with the architect hemoglobin a1c calibrator lot 54582uq02, list#04p52-01.It was noted that the calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot and although this lot may generate an active calibration curve, a shift to qc and patient results may occur.It was further observed that between the hba1c concentration range of 5.33% to 6.87%, there is no impact to assay performance, however, outside of this range a bias of greater than 3% may be seen with patient results.There have been no reported injuries or impact to patient management as a result of this issue.

• 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: 8708564
• MDR Text Key: 149685263
• Report Number: 1628664-2019-00397
• Device Sequence Number: 0
• Product Code: JIT
• Reporter Country Code: US
• PMA/PMN Number: K140654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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?: Yes
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-05/30/19-005-R
• Patient Sequence Number: 1