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 10/18/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys insulin on two cobas 8000 e 602 modules.The results did not compare to values obtained with a competitor method.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The sample was initially tested on the customer's immulite 2000 xpi platform, resulting in an insulin value of 204 uui/ml.The sample was repeated on the immulite system, resulting in a value that was similar, approximately 200 uui/ml.The sample was sent to a second site for testing on e 602 analyzer serial number (b)(4), resulting in an insulin value of < 0.200 uui/ml accompanied by a data flag.The sample was also sent to a third site for testing on a second e 602 analyzer (serial number unknown), resulting in a value of < 0.200 uui/ml accompanied by a data flag.

Manufacturer Narrative

Calibration signals were within expectations.Quality controls were within range on the day of the event.During investigations of the patient sample, c-peptide was also tested and the c-peptide result confirms the low insulin result obtained by the customer.The investigation could not identify a product problem.The customer states that the patient is injecting insulin.Based on the c-peptide value of the patient sample, it is very likely that the pancreas of the patient does not produce insulin and the patient requires insulin.The antibodies used in the insulin assay are highly specific for endogenous insulin.Per product labeling: "results for cross-reactivity with recombinant insulin analogs in a number of insulin methods have been published for example by two groups in france and the usa.The following results were published by owen et al.For the elecsys insulin assay : insulin lispro, insulin aspart, and insulin glargine were each tested in concentrations of 30, 100, 300, and 1000 miu/l in the absence of insulin.The results obtained were below the detection limit of the elecsys insulin assay (< 0.4 u/ml or < 2.78 pmol/l) at all the concentrations tested.".

Manufacturer Narrative

The correct serial number of the e 602 analyzer used at the second site is (b)(6).A sample from the patient was provided for investigation.The results obtained by the customer could be reproduced.It was determined the sample did not contain an interfering factor against the streptavidin component of the assay.Investigations are ongoing.

• 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: 12845205
• MDR Text Key: 285040714
• Report Number: 1823260-2021-03407
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 52940800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• 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: EUTHYROX; METFORMIN; OMEPRAZOLE; PRESSALIV
• Patient Age: 60 YR
• Patient Sex: Female