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

Catalog Number 07027559190

Device Problem High Test Results (2457)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer treated and tested the sample by precipitation by polyethylene glycol (peg) on the e801 module.The insulin result after peg treatment was 125 uu/ml.The c-peptide result after peg treatment was 4.04 ng/ml.The customer also performed a dilution experiment on the e801 module: c-peptide with 1:2 dilution was 21.1 ng/ml; final result was 42.2 ng/ml.C-peptide with 1:4 dilution was 12.1 ng/ml; final result was 48.4 ng/ml.C-peptide with 1:16 dilution was 4.80 ng/ml; final result was 76.8 ng/ml.Insulin with 1:16 dilution was 105 uu/ml; final result was 1680 uu/ml.The sample was requested for investigation.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys insulin (insulin) and elecsys c-peptide (c-peptide) on a cobas e801 module compared to the beckman method.This medwatch will cover the insulin results.Refer to medwatch with a1 patient identifier (b)(6) for information on the c-peptide results.The initial insulin result from the e801 module was 1000 uu/ml with a data flag.The initial c-peptide result from the e801 module was 34.9 ng/ml.The results were reported outside of the laboratory where they were questioned by the doctor.On (b)(6) 2021 the sample was sent to an external laboratory using the beckman method and the insulin result was 136.13 uu/ml and the c-peptide result was 20.35 ng/ml.The customer does not know which results are correct and suspects an interference.The e801 module serial number was not provided.

Manufacturer Narrative

Section b7 was updated.

Manufacturer Narrative

Calibration and qc were acceptable.The sample was submitted for investigation where the results were similar to the customer's results: c-peptide: 37.21 ng/ml; insulin: 1478 uu/ml.The sample was treated with heterophilic blocking tube (hbt): c-peptide: 37.58 ng/ml; insulin: 1478 uu/ml.The sample was treated by precipitation by polyethylene glycol (peg): insulin: 295 uu/ml.Based on the investigation results, an interfering factor was not identified.The lower insulin result after peg treatment indicate auto-anti insulin antibodies in the sample.Based on the quality validation data, a general insulin and c-peptide reagent issue can be excluded.The higher roche insulin results are consistent with the presence of anti-insulin antibodies which were recognized by the assay.The different c-peptide results between roche and beckman are due to different methods used by the respective manufacturer.The investigation did not identify a product problem.

• 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: 12342276
• MDR Text Key: 267267120
• Report Number: 1823260-2021-02415
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 07027559190
• Device Lot Number: 52941201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male