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

Model Number INSULIN

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

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 (b)(4).The result did not agree with the patient's clinical manifestation and the values measured using a competitor method.The sample initially resulted in an insulin value of 11.31 uu/ml and repeated as 11.47 uu/ml on a second e601 module.The sample values were reported outside of the laboratory to the doctor and questioned.The sample was then repeated using a competitor method, resulting in an insulin value of 300 uu/ml.

Manufacturer Narrative

The last calibration with lot 590959 was performed on 22-sep-2022.Per product labeling: "renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot" quality control results were within specified ranges.The sample was provided for investigation.The customer's elecsys insulin result could be reproduced.Elecsys c-peptide was also tested and resulted in a similar value as obtained by the customer.Both values fit clinically together as within or close to the expected value range.The elecsys insulin and c-peptide results are considered correct.The investigation could not identify a product problem.Medwatch fields a2, a3 and b7 have 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: 16019356
• MDR Text Key: 308528736
• Report Number: 1823260-2022-04122
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 00633436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• 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 Age: 32 YR
• Patient Sex: Male