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 11/03/2023

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 insulin results for patient samples.The following data was provided: (b)(6) 2023 patient 1 sample id (b)(6) all of the following results were generated on lot 37225lp64: initial result = 554 u/ml, repeat result 1:2 dilution = 757 u/ml, repeat result later = 739.87 u/ml, last diluted result = 375 u/ml.(b)(6) 2023 same patient, new sample.Undiluted result with lot 55221lp22 = 146 u/ml no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section d10 - concomitant product: arc insulin 100t rgt, 08k41-28, 37225lp64 deleted and replaced with arc insulin 100t rgt, 08k41-28, 55221lp22, section b5 - describe event or problem: lot number corrected from 37225lp64 to 54221lp21.

Event Description

The customer observed falsely elevated architect insulin results for patient samples.The following data was provided: (b)(6) 2023 patient 1 sample id (b)(6) all of the following results were generated on lot 54221lp21 : initial result = 554 u/ml, repeat result 1:2 dilution = 757 u/ml, repeat result later = 739.87 u/ml, last diluted result = 375 u/ml.1(b)(6) 2023 same patient, new sample.Undiluted result with lot 55221lp22 = 146 u/ml no impact to patient management was reported.

Manufacturer Narrative

D4 - expiration date updated from blank to 4/17/2024; h4 - device mfg date updated from blank to 6/5/2023.The complaint investigation for falsely elevated architect insulin results included a search for similar complaints, ticket trending review, labeling review, field data review, and device history record review.Return testing was not completed as returns were not available.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends or issues for the complaint product.Device history record review for the complaint lot did not identify any potential non-conformances, deviations, or non-conformances associated with the complaint issue.The overall performance of architect insulin reagent was reviewed using data gathered from customers worldwide.Review shows that the median patient results for lot 54221lp21 is within established limits and comparable with historical lots in the field, confirming no systemic issue for the lot.A review of applicable field data suggests that the performance is acceptable.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the architect insulin reagent kit, lot number 54221lp21, was identified.

Event Description

The customer observed falsely elevated architect insulin results for patient samples.The following data was provided: (b)(6) 2023 patient 1 sample id (b)(6) all of the following results were generated on lot 54221lp21: initial result = 554 u/ml, repeat result 1:2 dilution = 757 u/ml, repeat result later = 739.87 u/ml, last diluted result = 375 u/ml.(b)(6) 2023 same patient, new sample.Undiluted result with lot 55221lp22 = 146 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: 18300672
• MDR Text Key: 330163882
• Report Number: 3002809144-2023-00489
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 00380740169824
• UDI-Public: 00380740169824
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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: 01/17/2024
• 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 I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC INSULIN 100T RGT, 08K41-28, (B)(6).; ARC INSULIN 100T RGT, 08K41-28, (B)(6).; ARC INSULIN 100T RGT, 08K41-28, (B)(6).