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

Catalog Number	07027559190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys insulin on a cobas e 801 module (serial number (b)(4)).No questionable results were reported outside of the laboratory.The sample initially resulted in an insulin value of 37.2 uu/ml and it repeated as 19.2 uu/ml.
Additional Manufacturer Narrative
The patient sample was repeated because the initial value was high and the patient had no result history.An additional repeat of the sample was performed and this value was similar to the repeat value of 19.2 uu/ml.Calibration and control recoveries were within expectations.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch field a3 has been updated.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16567198
• Report Number: 1823260-2023-00873
• Device Sequence Number: 5729015
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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): 04/12/2023

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: 05/31/2024
• Device Catalogue Number: 07027559190
• Device Lot Number: 68250901
• 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: 03/05/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/12/2023
• 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
• Patient Sex: Male