MAUDE Adverse Event Report: ABBOTT GMBH 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	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated glucose result on the architect c4000, serial number (b)(6), for one patient.The sample was repeated and the results were lower.The following data was provided: sid (b)(6), initial result processed on (b)(6) 2025 = 429.9 mg/dl repeat results = 192 and 193 mg/dl.Reference range = adult: 70 to 105 mg/dl (fasting) no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect glucose result 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.Data and information provided by the customer were reviewed.Return testing was not completed as returns were not available.A search by product lot did not identify an increase in complaint activity.Review of tracking and trending for the architect glucose reagent list 03l82-22 did not identify an increase in complaint activity related to the complaint issue.The device history record did not identify any nonconformances related to the likely cause list number and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect glucose reagent list 03l82-22, lot 65679uq02.
Event or Problem Description
The customer reported a falsely elevated glucose result on the architect c4000, serial number (b)(6), for one patient.The sample was repeated and the results were lower.The following data was provided: sid (b)(6) initial result processed on (b)(6) 2025 = 429.9 mg/dl repeat results = 192 and 193 mg/dl.Reference range = adult: 70 to 105 mg/dl (fasting) 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: 21414286
• Report Number: 3002809144-2025-00045
• Device Sequence Number: 8215058
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: (01)00380740161583(17)250228(10)65679UQ02
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 03/26/2025

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: 02/28/2025
• Device Catalogue Number: 03L82-22
• Device Lot Number: 65679UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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 C4 PROC MOD, 02P24-01, (B)(6); ARC C4 PROC MOD, 02P24-01, (B)(6)
• Patient Sex: Unknown