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

Catalog Number	12017547122
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys insulin results for 6 patient samples on a cobas 8000 - cobas e 602 module.The customer questioned the low initial results which prompted them to repeat the patient samples.On (b)(6) 2024, sample 1 had an initial insulin result of 16.66 uu/ml.The sample was repeated on another e602 analyzer and the result was 21.1 uu/ml.On (b)(6) 2024, sample 2 had an initial insulin result of 7.10 uu/ml.The sample was repeated on another e602 analyzer and the result was 14.1 uu/ml.On (b)(6) 2024, the sample was repeated on the initial e602 analyzer and the result was 14.88 uu/ml.On (b)(6) 2024, sample 3 had an initial insulin result of 17.25 uu/ml.The sample was repeated on another e602 analyzer and the result was 35 uu/ml.On (b)(6) 2024, the sample was repeated on the initial e602 analyzer and the result was 35.23 uu/ml.On (b)(6) 2024, sample 4 had an initial insulin result of 3.21 uu/ml.The sample was repeated on another e602 analyzer and the result was 11.9 uu/ml.On (b)(6) 2024, the sample was repeated on the initial e602 analyzer and the result was 11.18 uu/ml.On (b)(6) 2024, sample 5 had an initial insulin result of 6.90 uu/ml.The sample was repeated on another e602 analyzer and the result was 15.7 uu/ml.On (b)(6) 2024, the sample was repeated on the initial e602 analyzer and the result was 15.08 uu/ml.On (b)(6) 2024, sample 6 had an initial insulin result of 3.16 uu/ml.The sample was repeated on another e602 analyzer and the result was 19.9 uu/ml.On (b)(6) 2024, the sample was repeated on the initial e602 analyzer and the result was 20.62 uu/ml.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration was last performed on (b)(6) 2024.The calibration and qc recovery data provided was acceptable.The alarm trace showed a sample aspiration alarm.The investigation is ongoing.
Additional Manufacturer Narrative
Based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20486535
• Report Number: 1823260-2024-03024
• Device Sequence Number: 19857622
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 11/25/2024

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 Catalogue Number: 12017547122
• Device Lot Number: 778999
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/26/2024
• 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