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

Model Number INSULIN

Device Problem High Test Results (2457)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The patient's sample was requested for an investigation, but the sample was not available for an investigation.The customer's calibration and qc data were acceptable.However, on the date of the event, the investigation discovered the level 2 qc material was not measured.The investigation reviewed the customer's alarm trace and noticed two abnormal aspiration alarms on the date of the event.Product labeling states, "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies which can affect the test results.In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys insulin results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).The patient's initial insulin result was reported outside the laboratory.The patient's doctor questioned the initial insulin result due to the result being too high and not matching the patient's medical history.The customer sent the patient's sample to another laboratory for further testing on a siemens centaur analyzer.Also, the patient's specimen was tested on a cobas 8000 e 801 module.On (b)(6) 2021, the patient's initial elecsys insulin result was 445.4 uu/ml.On (b)(6) 2021, the patient's insulin result on a centaur analyzer was 41.12 mu/l, and the patient's insulin result on an e 801 module was 442 uu/ml.The patient's doctor determined the siemens centaur result was correct due to the result correlating with the patient's medical history.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11438724
• MDR Text Key: 255860099
• Report Number: 1823260-2021-00693
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K001104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 47675200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• 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