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

Model Number INSULIN

Device Problems Incorrect Measurement (1383); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Event 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.

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
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16541581
• MDR Text Key: 311401814
• Report Number: 1823260-2023-00808
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/27/2023
• 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: CLOPIDOGREL; GLIFAGE; OLMY; OLMY; ROSUVASTATINA; SOMALGIN
• Patient Age: 60 YR
• Patient Sex: Male