MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT INSULIN REAGENT KIT; RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Catalog Number 08K41-28

Device Problem High Test Results (2457)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

The customer reported falsely elevated architect insulin, which was not consistent with patient's clinical presentation and/or history and provided the following data for 1 patient: insulin laboratory results: (unit of measure is uu/ml) (b)(6) 2023 result was 144.5, 12 oct 2023 result was 130.6, 23 oct 2023 result was 123.2, roche result was 22.91 (date unknown).Other laboratory results: a1c = 6.8%, fasting glucose = 154.71, insulin resistance = 8.8.There was no reported impact to patient management.

Manufacturer Narrative

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 Description

The customer reported falsely elevated architect insulin, which was not consistent with patient's clinical presentation and/or history and provided the following data for 1 patient: insulin laboratory results: (unit of measure is uu/ml).(b)(6) 2023 result was 144.5.(b)(6) 2023 result was 130.6.(b)(6) 2023 result was 123.2.Roche result was 22.91 (date unknown).Other laboratory results: a1c = 6.8%.Fasting glucose = 154.71.Insulin resistance = 8.8.There was no reported impact to patient management.

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, device history record review, and field data 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.The ticket search by lot did not identify an increase in complaint activity.Ticket and trending review did not identify any trends related to customer reported event.Device history review did not identify any non-conformances, potential non-conformances or deviations with the complaint lot and customer reported event.The overall performance of the architect insulin reagent in the field was reviewed using data gathered from customers worldwide.The review of field data indicated that the patient median result for lot 54221lp21 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Labeling was reviewed and sufficiently addresses the customer¿s reported issue.Based on the investigation, no systemic issue or deficiency was identified for the architect insulin reagent lot 54221lp21.

• Brand Name: ARCHITECT INSULIN REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
• 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: 18058912
• MDR Text Key: 327207581
• Report Number: 3002809144-2023-00455
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 00380740169824
• UDI-Public: 00380740169824
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08K41-28
• Device Lot Number: 54221LP21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)