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

Catalog Number 03L82-22

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated architect glucose results generated for a patient sample.The following data was provided: sample id (b)(6) initial result = 386 mg/dl, repeat result 2 hours later = 149 mg/dl, and 147 mg/dl no impact to patient management was reported.

Event Description

The customer observed falsely elevated architect glucose results generated for a patient sample.The following data was provided: sample id (b)(6) initial result = 386 mg/dl, repeat result 2 hours later = 149 mg/dl, and 147 mg/dl no impact to patient management was reported.

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.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 63582uq02 and complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.In this case, abnormal aspiration on the first result could have contributed to the customer¿s observation.As part of the troubleshooting the same sample was rerun on the same instrument and multiple times and generated lower results.The quality control was performing within the expected ranges, which shows that the assay was performing as expected.Based on this investigation, no systemic issue or deficiency was identified with the glucose reagent, lot number 63582uq02.Section h4 - device mfg date corrected from 5/9/2022 to 3/9/2023.

• Brand Name: GLUCOSE
• Type of Device: 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: 18409336
• MDR Text Key: 331503377
• Report Number: 3002809144-2023-00503
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 03L82-22
• Device Lot Number: 63582UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, (B)(6) ; ARC C8 PROC MOD, 01G06-11, (B)(6)