MAUDE Adverse Event Report: ABBOTT LABORATORIES GLUCOSE; HEXOKINASE, GLUCOSE

Catalog Number	03L82-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) (the complete sample id exceeded the allowed set of characters for this field) all available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated glucose results for one patient sample when running on the architect c4000 processing module.The following data was provided: on (b)(6) 2023 sid (b)(6): initial glucose result = 636 mg/dl; rerun result = 635 mg/dl (reference range: 70-99 mg/dl; critical range: > 400 mg/dl).The doctor questioned the result, and the customer reran the sample on an alternate architect and generated a result of 209 mg/dl.The sample was then rerun on the original instrument and generated a result of 210 mg/dl.The customer stated the qc was in range.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search by lot did not identify an increase in complaint activity for lot number 63245uq11 for the current issue.Ticket trending was reviewed and did not identify any related trends for the product for the issue.A review of the device history record did not identify any non-conformances or deviations associated with the reagent lot 63245uq11 and complaint issue.The customer performed troubleshooting by reanalyzing the samples to obtain lower results.The same sample when rerun on an alternate architect analyzer and on the original analyzer, generated lower results.The customer ran the specimen 10 times as precision, on each analyzer and stated that all results were near 200 as expected.Quality control was in range.Labeling was reviewed and adequately addresses the issue.Based on the investigation, no systemic issue or product deficiency of the architect glucose reagent lot 63245uq11 was identified.D4 - catalog # - initial: 03l82-21; updated on 15jan2024 to 03l82-42.
Event or Problem Description
The customer reported falsely elevated glucose results for one patient sample when running on the architect c4000 processing module.The following data was provided: on (b)(6) 2023 sid (b)(6): initial glucose result = 636 mg/dl; rerun result = 635 mg/dl (reference range: 70-99 mg/dl; critical range: > 400 mg/dl) the doctor questioned the result, and the customer reran the sample on an alternate architect and generated a result of 209 mg/dl.The sample was then rerun on the original instrument and generated a result of 210 mg/dl.The customer stated the qc was in range.There was no impact to patient management reported.

• Brand Name: GLUCOSE
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18017264
• Report Number: 3016438761-2023-00571
• Device Sequence Number: 20734022
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 11/30/2023
• Device Catalogue Number: 03L82-42
• Device Lot Number: 63245UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, (B)(4); ARC C4000 INTGR, 02P24-40, (B)(4)
• Patient Sex: Unknown