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

Model Number	INSULIN
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem 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.
Additional 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).
Additional 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
• 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; 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
• Report Number: 1823260-2021-02808
• Device Sequence Number: 14470164
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 11/17/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/26/2021; 12/07/2021
• 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: REFER TO SECTION B7
• Patient Age: 28 YR
• Patient Sex: Female