MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT GLUCOSE; HEXOKINASE, GLUCOSE

Catalog Number	03L82-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated glucose results generated from the architect analyzer and provided the following data: the initial test result was 11.89 mmol/l (214.2102 mg/dl), which was reported to the clinical physician.The retest results were 6.30 and 6.07 mmol/l (109.3571 mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer reported falsely elevated glucose results generated from the architect analyzer and provided the following data: the initial test result was 11.89 mmol/l (214.2102 mg/dl), which was reported to the clinical physician.The retest results were 6.30 and 6.07 mmol/l (109.3571 mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and supported the complaint issue without indication of any additional issues.A search for similar complaints did not identify an increase in complaint activity for lot 68191uq04.A review of tracking and trending for the glucose assay did not identify any trends related to the complaint issue.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 68191uq04 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified with the glucose reagent, lot number 68191uq04.

• Brand Name: ARCHITECT 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: 23525791
• Report Number: 3002809144-2025-00358
• Device Sequence Number: 15994426
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: (01)00380740161583(17)260430(10)68191UQ04
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 04/30/2026
• Device Catalogue Number: 03L82-22
• Device Lot Number: 68191UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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, C1602093; ARC C16K PRC MOD, 03L77-01, C1602093
• Patient Sex: Unknown