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

Model Number	INSULIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two samples from the patient were submitted for investigation.The customer's insulin results were reproduced at the investigation site.A heterophilic interference was excluded.Investigations are ongoing.The follow up/corrective actions he sample was requested for investigation.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Erroneous high results were generated by a cobas 6000 e 601 module.The event involved 1 patient with elecsys insulin.The provided patient's age was (b)(6).The patient's gender was female.
Additional Manufacturer Narrative
Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.Based on this data, a general reagent issue can be excluded.

• Brand Name: ELECSYS INSULIN
• Common Device Name: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8556052
• Report Number: 1823260-2019-90159
• Device Sequence Number: 16717842
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: INSULIN
• Device Lot Number: 31572405
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1