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 11/16/2023

Event Type  malfunction  

Event Description

The customer reported falsely elevated architect insulin results which questioned by the physician for a male patient from different draws.The physician stated the patient taking treatment and insulin results should be within reference range.The following data was provided: on (b)(6) 2023 sid (b)(6) 300 u/ml /redrawn and repeated sid (b)(6) 300 u/ml /redrawn and repeated on (b)(6) 2023 sid (b)(6) 300u/ml.Laboratory reference range for insulin=2 to 20 u/ml no impact to patient management was reported.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (b)(6),(b)(6) and (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint evaluation 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 accuracy testing of architect insulin reagent lot number 56221lp24.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.The ticket search determined that there is as expected complaint activity for the likely cause lot 56221lp24.The accuracy testing was performed for reagent lot 56221lp24 using an internal insulin panel which was tested with a retained kit of the likely cause reagent lot.Acceptance criteria were met, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect insulin reagent lot number 56221lp24.

Event Description

The customer reported falsely elevated architect insulin results which questioned by the physician for a male patient from different draws.The physician stated the patient taking treatment and insulin results should be within reference range.The following data was provided: on 16nov2023 sid (b)(6) = > 300 u/ml /redrawn and repeated sid 231106595302= > 300 u/ml /redrawn and repeated on 17nov2023 sid (b)(6) => 300 u/ml.Laboratory reference range for insulin=2 to 20 u/ml no impact to patient management was reported.

• 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: 18427066
• MDR Text Key: 331926848
• Report Number: 3002809144-2024-00001
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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: 56221LP24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, ISR51690; ARC I2SR REFURB-SEKAT, 03M74-97, ISR51690
• Patient Sex: Male