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 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided.Patient identifier: complete entry = (b)(6).Reporter complete entry = (b)(6).

Event Description

The customer obtained a falsely elevated architect insulin result.On (b)(6) 2021, sample id (b)(6) generated 361.4 pmol/l.The sample was retested twice on (b)(6) 2021 and generated 253.62 and 250.22 pmol/l.No impact to patient management was reported.

Manufacturer Narrative

Investigation of the customer's issue included a review of the complaint text, complaint activity, trending reports, labeling and device history records.Additionally, in-house retained kit testing of the complaint lot was performed.Return testing was not completed as returns were not available.Review of the trending reports for the architect insulin assay did not identify any trends.Device history record review for the complaint lot did not identify any potential non-conformances, deviations or non-conformances.Labeling was reviewed and sufficiently addresses the complaint issue.Accuracy testing was performed to evaluate the performance of reagent lot 29821lp68.An internal insulin panel was tested with retained kits of the complaint lot.Acceptance criteria was met indicating the product performance is acceptable.Based on this investigation, no systemic issue or deficiency of the architect insulin assay was identified.H4 device mfg date was changed from 4/7/2021 to 4/27/2021.The incorrect date was entered in error.

• 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: 12668451
• MDR Text Key: 278015903
• Report Number: 3002809144-2021-00610
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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, ISR60522