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

Model Number	08P4320
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated hemoglobin a1c results generated on the alinity c analyzer on multiple patients.Example sids provided: (b)(6).The customer observes > 129 mmol/ml and upon repeat the results are normal.Results provided: sid (b)(6).First run >129.51 mmol/mol / >129.51 mmol/mol.1rst rerun 38.89 mmol/mol / 56.33 mmol/mol.2nd rerun 38.44 mmol/mol / 56.23 mmol/mol.There was no impact to patient management reported.
Additional Manufacturer Narrative
Patient identifier (b)(6).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 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 alinity c hemoglobin a1c reagent kit (list number 08p4320).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.All available patient information was included.No additional information was provided.

• Brand Name: ALINITY C HEMOGLOBIN A1C REAGENT KIT
• 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: 14842667
• Report Number: 3016438761-2022-00281
• Device Sequence Number: 4794384
• Product Code: PDJ
• UDI-Device Identifier: 00380740135591
• UDI-Public: 00380740135591
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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 Model Number: 08P4320
• Device Catalogue Number: 08P43-20
• 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: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC01421
• Patient Sex: Unknown