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

Catalog Number	07027559190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they have received questionable test results for one patient tested with elecsys insulin on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect values were reported outside of the laboratory.The reporter states that the patient showed very high insulin values > 6000 when the patient is under the administration of acrapid insulin.No units of measure were provided for insulin.When the patient is under therapy with lantus and apidra insulins, the insulin values of the patient are very low at 10-20.The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
Product labeling states: "intended use: immunoassay for the in vitro quantitative determination of human insulin in human serum and plasma." product labeling also states: "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies.15,9 insulin bound to these antibodies is at least partially recognized by the antibodies used in the elecsys insulin assay.16".As the intended use of the elecsys insulin assay is the determination of human insulin, this may possibly explain the high result when the patient was given actrapid.Actrapid is human insulin.Furthermore, the patient has insulin antibodies.Insulin bound to anti-insulin antibodies are known to be at least partially recognized by the elecsys insulin assay.No sample from the patient was available for further investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 13731424
• Report Number: 1823260-2022-00655
• Device Sequence Number: 14654262
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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 Catalogue Number: 07027559190
• Device Lot Number: ASKU
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/11/2022
• 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: ACTRAPID; APIDRA; LANTUS
• Patient Sex: Unknown