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

Catalog Number 08K41-74

Device Problem High Test Results (2457)

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

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

No patient identifier or demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer identified falsely elevated architect insulin results for one patient.The following was provided: initial result 111 uu/ml, new sample after several days 50 uu/ml (repeated with dilution at 81 uu/ml).No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for architect insulin reagent lot 29821lp68.A review of tickets was performed and did not identify an increased complaint activity related to the falsely elevated patient results.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed to evaluate the performance of reagent lot 29821lp68.An internal architect insulin panel was tested with retained kits of the likely cause reagent lot 29821lp68.Acceptance criteria was met, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect insulin reagent lot 29821lp68 was identified.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12584628
• MDR Text Key: 278003117
• Report Number: 3002809144-2021-00591
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2022
• Device Catalogue Number: 08K41-74
• Device Lot Number: 29821LP68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR53585