MAUDE Adverse Event Report: ABBOTT GMBH 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	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated glucose result generated on the architect c16000 processing module on a patient.Results provided: 13.14 / 5.87 / 5.90 mmol/l (reference range: 3.9-6.11 mmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated glucose result included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Trending review determined no related trend for the issue for the product.Device history record review on lot 66606uq06 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the architect glucose reagent, lot number 66606uq06, was identified.
Event or Problem Description
The customer reported a falsely elevated glucose result generated on the architect c16000 processing module on a patient.Results provided: 13.14 / 5.87 / 5.90 mmol/l (reference range: 3.9-6.11 mmol/l) no impact to patient management was reported.

• Brand Name: GLUCOSE
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21477206
• Report Number: 3002809144-2025-00061
• Device Sequence Number: 16991960
• Product Code: CFR
• UDI-Device Identifier: 00380740161590
• UDI-Public: (01)00380740161590(17)250630(10)66606UQ06
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 06/30/2025
• Device Catalogue Number: 03L82-42
• Device Lot Number: 66606UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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 C16K PRC MOD, 03L77-01, C1601220; ARC C16K PRC MOD, 03L77-01, C1601220
• Patient Sex: Unknown