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

Catalog Number 07027559190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 02/28/2023

Event Type  malfunction  

Event 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.

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
• 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: 16567198
• MDR Text Key: 311825687
• Report Number: 1823260-2023-00873
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027559190
• Device Lot Number: 68250901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• 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
• Patient Sex: Male