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 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.As the roche elecsys results were repeatable, the most likely cause was that the unknown competitor method measures the novorapid insulin (insulin aspart, genetically engineered human insulin analogon) taken by the patient which is not recognized by the elecsys insulin assay.

Event Description

The initial reporter received questionable elecsys insulin results for one patient tested on a cobas 8000 e601 module serial number (b)(4).On (b)(6) 2022, the initial insulin result was 0.200 u/ml, and it was accompanied by a data flag.The repeat result was 0.221 u/ml.On (b)(6) 2022, the repeat result performed on a competitor instrument (chemiluminescence instrument) was 118 mu/l.On (b)(6) 2022, the repeated result was performed on the cobas 8000 e601 module and the result was 0.343 u/ml and 0.310 u/ml.On (b)(6) 2022, the repeated result was performed on the cobas 8000 e601 module and the result was 1.15 u/ml, with a dilution ratio of 2:1.The questionable results were reported outside the laboratory.

• 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: 15668363
• MDR Text Key: 302497186
• Report Number: 1823260-2022-03339
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 58660701
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• 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
• Treatment: NOVORAPID - ONE UNIT