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

Model Number	INSULIN
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys insulin assay on a cobas 6000 e601 module, serial number 26e4-17.An interference is suspected by the customer.On (b)(6) 2023, a first sample from the patient resulted in an insulin value of >1000 u/l, accompanied by a data flag and repeated also with a value of >1000 u/l, accompanied by a data flag.On (b)(6) 2023, a second sample from the patient resulted in an insulin value of >1000 u/l, accompanied by a data flag.This sample was repeated in a different laboratory using an unknown method, resulting in an insulin value of 261 mui/ml.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration and quality control results were acceptable.Instrument performance testing was within specifications.For the medications, the patient is taking no interference is known with the elecsys insulin assay.It was asked but no further patient information could be provided.Based on the information, a general reagent issue can be excluded.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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16541581
• Report Number: 1823260-2023-00808
• Device Sequence Number: 12285371
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/19/2023

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: 10/31/2023
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 63343600
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL; GLIFAGE; OLMY; OLMY; ROSUVASTATINA; SOMALGIN
• Patient Age: 60 YR
• Patient Sex: Male