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

Catalog Number	04P52-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HEMOGLOBIN A1C CALIBRATORS
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8785830
• Report Number: 1628664-2019-00495
• Device Sequence Number: 1925694
• Product Code: JIT
• UDI-Device Identifier: 00380740102722
• UDI-Public: 00380740102722
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: 06/27/2019
• Initial Report FDA Received Date: 07/12/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C8000, LIST 01G06-11; SERIAL (B)(4)