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

Catalog Number	07027559190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys insulin results for one patient tested with a cobas 8000 e 801 module serial number (b)(4).The patient's initial elecsys insulin result was not reported outside the laboratory.The customer performed dilution testing with the sample.For further testing, the customer sent the sample to a different laboratory and the sample was tested on an alinity analyzer.The patient's initial insulin result was 1000 uu/ml with a data flag.The patient's insulin result with a 1:5 dilution was 3755 uu/ml.The patient's insulin result with a 1:10 dilution was 3800 uu/ml.The patient's insulin result on the alinity analyzer was 280 uu/ml.
Additional Manufacturer Narrative
Product labeling states, "measuring range 0.4-1000 u/ml or 2.78-6945 pmol/l (defined by the limit of detection and the maximum of the master curve).Values below the limit of detection are reported as 0.4 u/ml (< 2.78 pmol/l).Values above the measuring range are reported as 1000 u/ml (> 6945 pmol/l)." for dilution testing, product labeling states, "not necessary due to the broad measuring range." the investigation determined the high elecsys insulin results compared to the alinity analyzer was consistent with the elecsys insulin assay detecting the auto-insulin antibody complexes.For assay limitations, product labeling states, "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies.Insulin bound to these antibodies is at least partially recognized by the antibodies used in the elecsys insulin assay." based on the provided information, the investigation did not identify a product problem.The 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14438272
• Report Number: 1823260-2022-01444
• Device Sequence Number: 5733025
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/18/2022

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 Catalogue Number: 07027559190
• Device Lot Number: ASKU
• 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: 04/30/2022
• Initial Report FDA Received Date: 05/19/2022
• 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
• Patient Sex: Unknown