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	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys insulin assay on a cobas 6000 e601 module, serial number (b)(4).The result did not agree with the patient's clinical manifestation and the values measured using a competitor method.The sample initially resulted in an insulin value of 11.31 uu/ml and repeated as 11.47 uu/ml on a second e601 module.The sample values were reported outside of the laboratory to the doctor and questioned.The sample was then repeated using a competitor method, resulting in an insulin value of 300 uu/ml.
Additional Manufacturer Narrative
The last calibration with lot 590959 was performed on 22-sep-2022.Per product labeling: "renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot" quality control results were within specified ranges.The sample was provided for investigation.The customer's elecsys insulin result could be reproduced.Elecsys c-peptide was also tested and resulted in a similar value as obtained by the customer.Both values fit clinically together as within or close to the expected value range.The elecsys insulin and c-peptide results are considered correct.The investigation could not identify a product problem.Medwatch fields a2, a3 and b7 have been updated.

• 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: 16019356
• Report Number: 1823260-2022-04122
• Device Sequence Number: 15177099
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• 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): 02/17/2023

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: 10/31/2023
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 00633436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/17/2023
• 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
• Patient Age: 32 YR
• Patient Sex: Male