MAUDE Adverse Event Report: ABBOTT LABORATORIES HEMOGLOBIN A1C REAGENT; HEMOGLOBIN A1C TEST SYSTEM

Model Number	4P52-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Through internal data analysis, abbott has identified that for the architect hemoglobin a1c (a1c), ln 04p52-20, and alinity c hba1c, ln 08p43-20 and 08p43-77, reagent kits the current set value for low linearity range for total hemoglobin is too low when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low total hemoglobin values.This may lead to the potential for whole blood %hba1c results to be erratic.The issue has the potential to result in falsely elevated hemoglobin %a1c and hemoglobin a1c patient results.There has been no reported adverse impact to patient management as a result of this issue.
Additional Manufacturer Narrative
Continued information for correction/removal reporting number: 3016438761-06/16/22-001-c.During the investigation to this issue, internal data analysis found the current set value for low linearity range for the total hemoglobin is too low when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low total hemoglobin values.It was identified that a revision to the total hemoglobin low linearity values for the architect & alinity hemoglobin a1c whole blood and hemolysate applications was required.To address the linearity issue, for whole blood application, the thbwb low linearity value has been updated to 53.8278 umol/l; for the hemolysate application, the thbh low linearity value has been updated to 1250 umol/l to prevent the potential for falsely elevated results.A product correction letter was sent to all customers who have received impacted lots of the architect hemoglobin a1c (list number 04p52-20) and alinity c hemoglobin a1c reagent kit (list number 08p4320 and 08p4377).The letter informs the customer of the issue and provides them with instructions for necessary actions to perform, which includes immediately installing the updated assay file versions (based on their impacted product and sample application) and then manually configuring the low linearity value.Continued for all in date lots for both architect and alinity hemoglobin a1c reagents: brand name, catalog no., lot number, expiration date, udi#, and device mfg date: alinity c hemoglobin a1c reagent kit, 08p43-20, 59561uq04, exp date: 04jul2022,(b)(4), mfg date: 05apr2021.Alinity c hemoglobin a1c reagent kit, 08p43-20, 59779uq05, exp date: 20aug2022, (b)(4), mfg date: 21may2021.Alinity c hemoglobin a1c reagent kit, 08p43-20, 60229uq07, exp date: 08oct2022, (b)(4), mfg date: 09jul2021.Alinity c hemoglobin a1c reagent kit, 08p43-20, 60540uq09, exp date: 19dec2022, (b)(4), mfg date: 20sep2021.Alinity c hemoglobin a1c reagent kit, 08p43-20, 61011uq10, exp date: 20jan2023, (b)(4), mfg date: 21oct2021.Alinity c hemoglobin a1c reagent kit, 08p43-20, 61349uq01, exp date: 02apr2023, (b)(4), mfg date: 03jan2022.Alinity c hemoglobin a1c reagent kit, 08p43-20, 61658uq01, exp date: 26apr2023, (b)(4), mfg date: 27jan2022.Alinity c hemoglobin a1c reagent kit, 08p43-77, 59801uq04, exp date: 04jul2022, (b)(4), mfg date: 05apr2021.Alinity c hemoglobin a1c reagent kit, 08p43-77, 60763uq09, exp date: 19dec2022, (b)(4), mfg date: 20sep2021.Hemoglobin a1c, 04p52-20, 59868uq05, exp date: 11aug2022, (b)(4), mfg date: 12may2021.Hemoglobin a1c, 04p52-20, 59900uq06, exp date: 08sept2022, (b)(4), mfg date: 10jun2021.Hemoglobin a1c, 04p52-20, 60138uq07, exp date: 11oct2022, (b)(4), mfg date: 12jul2021.Hemoglobin a1c, 04p52-20, 60237uq08, exp date: 04nov2022, (b)(4), mfg date: 05aug2021.Hemoglobin a1c, 04p52-20, 60535uq08, exp date: 11nov2022, (b)(4), mfg date: 12aug2021.Hemoglobin a1c, 04p52-20, 60698uq09, exp date: 29dec2022, (b)(4), mfg date: 30sep2021.Hemoglobin a1c, 04p52-20, 60880uq10, exp date: 26jan2023, (b)(4), mfg date: 27oct2021.Hemoglobin a1c, 04p52-20, 61066uq11, exp date: 26feb2023, (b)(4), mfg date: 24nov2021.Hemoglobin a1c, 04p52-20, 61246uq01, exp date: 04arp2023, (b)(4), mfg date: 05jan2022.Hemoglobin a1c, 04p52-20, 61250uq01, exp date: 10apr2023, (b)(4), mfg date: 11jan2022.

• Brand Name: HEMOGLOBIN A1C REAGENT
• Common Device Name: HEMOGLOBIN A1C TEST SYSTEM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14787869
• Report Number: 3016438761-2022-00238
• Device Sequence Number: 20096405
• Product Code: PDJ
• UDI-Device Identifier: 00380740102746
• UDI-Public: 00380740102746
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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: 07/07/2022
• Device Model Number: 4P52-20
• Device Catalogue Number: 04P52-20
• Device Lot Number: 59588UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 3016438761-06/16/22-001
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C PROCESSING MODULE, LIST NUMBER 03R67; ARCHITECT C4000, LIST NUMBERS 01R24, 01R25, 02P24; ARCHITECT C8000, LIST NUMBER 01G06
• Patient Sex: Unknown