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

Model Number INSULIN

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys insulin results for three patients tested on a cobas 8000 e 602 module serial number (b)(4).The customer also performed testing on a siemens immulite 2000 analyzer to compare results and to detect any sample or reagent interferences.The questionable results were reported outside the laboratory.This medwatch is for elecsys insulin.Refer to medwatch with a1 patient identifier pt-(b)(6) for the elecsys c-peptide assay.

Manufacturer Narrative

On (b)(6) 2020, the patient had a new sample collected.The customer performed elecsys insulin and elecsys c-peptide testing on a cobas 8000 e 602 module and a siemens immulite 2000 analyzer.The patient's results on the e 602 module were insulin 57.45 uu/ml, c-peptide 1.44 ng/ml, molar ratio insulin/c-peptide 0.83, and peg recovery 8%.The patient's results on the siemens immulite 2000 analyzer were insulin 55.6 mcu/ml, c-peptide 1.05 ng/ml, and molar ratio insulin/c-peptide 1.15.No questionable results were reported outside the laboratory and no adverse events occurred.

Manufacturer Narrative

Updated medwatch field a2.Patient 3's date of birth is (b)(6)-1965.On (b)(6)-2020, patient 3 had a new sample collected for further testing.Patient 3's results on the e 602 module were insulin 57.45 uu/ml, c-peptide 1.44 ng/ml, molar ratio insulin/c-peptide 0.83, and peg recovery 8%.Patient 3's results on the siemens immulite 2000 analyzer were insulin 55.6 mcu/ml, c-peptide 1.05 ng/ml, and molar ratio insulin/c-peptide 1.15.No questionable results were reported outside the laboratory.A sample from patient 3 was provided for an investigation.No samples from patient 1 and patient 2 were available for an investigation.The investigation confirmed the customer's insulin results and peg precipitation results for patient 3.The investigation confirmed minimal reactivity with free insulin in the sample, and the testing showed that high molecular weight proteins like immunoglobulins, igg, are present in the fraction of the sample, which shows reactivity to insulin, suggesting the presence of autoantibodies.Further clarification of the findings was not possible due to the lack of remaining sample.Based on the available data, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10515394
• MDR Text Key: 213077892
• Report Number: 1823260-2020-02231
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• PMA/PMN Number: K001104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR