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

Catalog Number	07027559190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant low results for 2 patient samples tested for elecsys insulin (insulin) on a cobas e 801 analytical unit.Patient 1 initial result was < 0.4 uu/ml.The repeat result from a competitor method was 26.6 miu/l patient 2 initial result was < 0.4 uu/ml.The repeat result from a competitor method was 67.2 miu/ml.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The competitor method was siemens.Section e1, facility name continued: (b)(6).
Additional Manufacturer Narrative
Sections a2 and a3a were updated.Section b3 was updated.Section b7 was updated.The initial result for patient 2 was obtained on (b)(6) 2025.
Additional Manufacturer Narrative
Calibration and qc were acceptable.No preanalytical issues were identified.Product labeling states: "results for cross-reactivity with recombinant insulin analogs in a number of insulin methods have been published for example by two groups in france and the usa.The following results were published by owen et al.For the elecsys insulin assay: insulin lispro, insulin aspart, and insulin glargine were each tested in concentrations of 30, 100, 300, and 1000 miu/l in the absence of insulin.The results obtained were below the detection limit of the elecsys insulin assay (< 0.4 u/ml or < 2.78 pmol/l) at all the concentrations tested." the investigation determined that the lower elecsys insulin results compared to the siemens method were that the siemens method measures the patient's insulin medication, while the elecsys insulin assay does not.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: 22194073
• Report Number: 1823260-2025-01815
• Device Sequence Number: 8837050
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 09/12/2025

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): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 08/29/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/07/2025; 09/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1 - EMENTIN OPHTHALMIC SOLUTION; PATIENT 1 - FERROUS GLUCO-B S.C; PATIENT 1 - INSUPEN INSULIN PEN; PATIENT 1 - LIVALO; PATIENT 1 - NEOSTIGMINE METHYLSUFATE; PATIENT 1 - NOVORAPID FLEXPEN; PATIENT 1 - NOVORAPID INSULIN; PATIENT 1 - OGTT INSULIN; PATIENT 1 - RYZODEC; PATIENT 1 - SUPER SALOON; PATIENT 1 - TRESIBA FLEXTOUCH; PATIENT 1 ¿ AMARYL; PATIENT 1 ¿ ELTROXIN; PATIENT 1 ¿ JARDIANCE; PATIENT 1 ¿ REPAGLINIDE; PATIENT 1 ¿ SOLIQUA; PATIENT 1 ¿ VYTORIN; PATIENT 2 ¿ ACTOS; PATIENT 2 ¿ EXFORGE F.C.; PATIENT 2 ¿ GINCARE; PATIENT 2 ¿ HARNALIDGE; PATIENT 2 ¿ LIVALO; PATIENT 2 ¿ MIKELAN LA OPTHALMIC SOLUTION; PATIENT 2 ¿ NICAN F.C.; PATIENT 2 ¿ NOVORAPID FLEX PEN; PATIENT 2 ¿ OKWE; PATIENT 2 ¿ RYZODEG FLEXTOUCH(70/30); PATIENT 2 ¿ XALATAN
• Patient Age: 51 YR
• Patient Sex: Female