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

Model Number INSULIN

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter complained of discrepant results for 3 samples from 1 patient tested for elecsys insulin (insulin) on a cobas 8000 e 602 module compared to the architect method.The roche results were reported outside of the laboratory where they were questioned as they did not correspond to the patient¿s clinical diagnosis and repeat testing by another analyzer was requested.The patient had come to the hospital due to symptoms of hypoglycemia.On (b)(6) 2021 the result on the e602 module was 19.1 uu/ml.The result from the architect method was 300 uu/ml.On the morning of (b)(6) 2021 the result from the 2nd sample on the e602 module was 0.4 uu/ml.The result from the architect method was 92.98 uu/ml.On the afternoon of (b)(6) 2021 the result from the 3rd sample on the e602 module was 6.0 uu/ml.The result from the architect method was 263.93 uu/ml.The customer believes the architect results to be correct.The e602 module serial number was not provided.

Manufacturer Narrative

On (b)(6) 2021 the customer sent another sample from the patient for testing by 2 other manufacturers.The insulin result by the sysmex method was 164.49 uu/ml (reference range: 2.6-24.9uu/ml).The insulin result by the mindary method was 7.5 uiu/ml (reference range: 2.2-25uiu/ml).The sample was also tested for c-peptide where the result by the sysmex method was 0.5 ng/ml (reference range: 0.8-4.0 ng/ml) and the result by the mindary method was 0.3 ng/ml (reference range: 1-4.8 ng/ml).

Manufacturer Narrative

Calibration was acceptable.Multiple warnings were observed on the customer's qc data from the dates of sample measurement.Three samples from the patient were received for investigation and tested for insulin on an e411 instrument and an e801 module: sample from (b)(6)2021: cobas e411: 14.04 uu/ml, cobas e801 pro: 14.8uu/ml sample from (b)(6)-2021: cobas e411: 1.83 uu/ml cobas e801 pro: 2.52uu/ml sample from (b)(6)-2021: cobas e411: 5.79 uu/ml cobas e801 pro: 6.28uu/ml the 3 samples were also tested for c-peptide: sample from (b)(6)-2021: cobas e411: 0.988 ng/ml, cobas e801 pro: 0.937 ng/ml sample from (b)(6)-2021: cobas e411: 0.159 ng/ml, cobas e801 pro: 0.163 ng/ml sample from (b)(6)-2021: cobas e411: 0.437 ng/ml, cobas e801 pro: 0.411 ng/ml the c-peptide results correspond to the insulin results.The samples were investigated further and no interfering factor was identified.Based on the investigation results, the investigation did not identify a product problem.The insulin assay is performing within specifications.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12526401
• MDR Text Key: 273223322
• Report Number: 1823260-2021-02808
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K001104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 47675202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REFER TO SECTION B7
• Patient Age: 28 YR
• Patient Sex: Female