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

Catalog Number	07027559190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned high results for 2 samples drawn on (b)(6) 2018 from 1 patient tested for elecsys insulin (insulin) on a cobas e 801 module.The customer suspects an interference in the patient sample as the results don't correspond to patient's clinical picture.The first sample was obtained after 4 hours fasting and had an initial insulin result of 97.1 uu/ml.The 2nd sample was obtained after 16 hours fasting and had an insulin result of 87.4 uu/ml.The high insulin results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).On (b)(6) 2018 the customer performed interference testing on the 2 samples: after scantibodies hbt treatment, the insulin results were 92.7 uu/ml for the 1st sample and 86.6 uu/ml for the 2nd sample.The 2 samples were also treated and underwent polyethylene glycol (peg) testing where the insulin result for the 1st sample was 4.03 uu/ml (calculated result of 16.12 uu/ml) and the insulin result for the 2nd sample was 3.30 uu/ml (calculated result of 13.2 uu/ml).Both samples were submitted for investigation and tested on an e 801 module with insulin reagent lot number 269698.The insulin result from the 1st sample was 104 uu/ml and the insulin result from the 2nd sample was 94.3 uu/ml.The customer's results were reproduced.Investigations are ongoing.
Additional Manufacturer Narrative
As the qc recovery at the customer site and investigation were within specified ranges, a general reagent issue can be excluded.The investigation did not identify a product problem.The identified anti-insulin auto-antibodies in the patient sample are documented in product labeling for the assay.
Additional Manufacturer Narrative
The sample for investigation was sent to an external laboratory for testing by the siemens immulite method.The insulin result was 592.0 uu/ml.This result was confirmed by dilution analysis.The investigation results suggest that the high insulin results are caused by anti-insulin auto-antibodies in the patient sample.

• Brand Name: ELECSYS INSULIN
• Common Device Name: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7706083
• Report Number: 1823260-2018-02411
• Device Sequence Number: 13636403
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2018

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: 02/28/2019
• Device Catalogue Number: 07027559190
• Device Lot Number: 269698
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 07/05/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 09/04/2018; 09/25/2018
• 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 DOES NOT TAKE MEDICATION
• Patient Age: 22 YR