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

Catalog Number	07027559190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 core unit serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant low results for 2 patient samples tested for elecsys insulin (insulin) on a cobas 8000 core unit.Patient 1 initial result was 3.94 pmol/l.The repeat result was 401 pmol/l.Patient 2 initial result was 39.5 pmol/l.The repeat result was 1383 pmol/l.
Additional Manufacturer Narrative
The investigation determined the event was due to the customer's preclean m system reagent.The customer's material was submitted for investigation.It was found that the k ion content was abnormal.This abnormality is consistent with the customer mixing the solution in the bottle with other system reagents.The customer replaced the preclean m system reagent with a new bottle, and the issue was resolved.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21986496
• Report Number: 1823260-2025-01427
• Device Sequence Number: 8480219
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/09/2025

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: 12/31/2025
• Device Catalogue Number: 07027559190
• Device Lot Number: 811059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown