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

Catalog Number 04P52-01

Device Problems Failure to Calibrate (2440); High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2019

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

The customer received error code 1353 calibration failure, calibration factor out of range and controls out of range high while using the architect hba1c calibrator, list 04p52-01, lot 54582uq02.No discrepant patient results generated.No impact to patient management was reported.

• 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: 8734315
• MDR Text Key: 149689541
• Report Number: 1628664-2019-00467
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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: 06/10/2019
• 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