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

Catalog Number	04P52-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: sample id (b)(6).No other patient specific information available.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 or Problem Description
The customer reported a falsely elevated architect hba1c result for one patient sample and variation of control results while using architect hba1c calibrator, list 04p52-01, lot 54582uq02.Sample id (b)(6) generated an initial result of 11.1% and retest two days later generated 5.2%.No impact to patient management was reported.

• Brand Name: ARCHITECT HEMOGLOBIN A1C
• Common Device Name: HEMOGLOBIN A1C CALIBRATORS
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8734306
• Report Number: 1628664-2019-00465
• Device Sequence Number: 1937510
• Product Code: JIT
• UDI-Device Identifier: 00380740102722
• UDI-Public: 00380740102722
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K140654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2020
• Device Catalogue Number: 04P52-01
• Device Lot Number: 54582UQ02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1628664-05/30/19-005-R
• Patient Sequence Number: 1