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

Model Number	INSULIN
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1823260-2022-03339
• Device Sequence Number: 6321221
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVORAPID - ONE UNIT
• Patient Sex: Unknown