MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS INSULIN; IMMUNOREACTIVE INSULIN TEST SYSTEM

Catalog Number	12017547122
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of high results for 2 samples from 1 patient tested for elecsys insulin (insulin) on a cobas e 411 immunoassay analyzer.On (b)(6) 2023 the patient had an insulin result of 962.8 uu/ml with a data flag from the e411 analyzer.The repeat result was 960.8 uu/ml with a data flag.On (b)(6) 2023 a new sample was obtained and the result from the e411 analyzer was 966.0 uu/ml with a data flag.This sample was sent to another laboratory where the result from the maglumi method was 99.61 uu/ml and the result from the atellica method was 31.03 uu/ml.
Additional Manufacturer Narrative
The e411 analyzer serial number is (b)(6).Qc was acceptable.On (b)(6) 2023 the customer treated the sample from (b)(6) 2023 with polyethylene glycol to test for interference and the result was 40.62 uu/ml.The investigation is ongoing.
Additional Manufacturer Narrative
The insulin result from the atellica method of 31.03 uu/ml was believed to be correct as this coincides with the patient's clinical history.The calibration data provided from 06-aug-2023 was acceptable.Qc data provided between 05-jun-2023 and 05-aug-2023 was acceptable.The investigation determined the event was consistent with the presence of anti-insulin antibodies in the patient sample which are recognized by the elecsys insulin assay.This is confirmed by the result received by the customer after treating the sample with polyethylene glycol.A general reagent issue can be excluded as the provided quality control data is within expectations.Product labeling states: "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies which can affect the test results." the investigation did not identify a product problem.

• Brand Name: ELECSYS INSULIN
• Common Device Name: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17817409
• Report Number: 1823260-2023-03107
• Device Sequence Number: 18104292
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): Y
• Initial Reporter Country: AR
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 12017547122
• Device Lot Number: 63343603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPART INSULIN ¿ 3X/DAY; NPH OR ISOPHANE INSULIN ¿ 3X DAY; UNSPECIFIED CHOLESTEROL MEDICATION; UNSPECIFIED HYPERTENSION MEDICATION
• Patient Sex: Unknown