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

Model Number INSULIN

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Instrument maintenance was up to date.The customer was able to reproduce the roche results and the siemens results.Qc for both methods were acceptable.Calibration data was acceptable.

Event Description

The initial reporter complained of discrepant results for 1 patient tested for elecsys insulin on a cobas 8000 e 602 module compared to the siemens method.The initial result from the e602 module was 0.200 uu/ml with a data flag.The sample was repeated by the siemens method with a result of 67.15 mu/l.The patient had injected aspart insulin the day before the test.The customer suspects a cross-reaction with the insulin affecting the roche results.The questionable results were not reported outside of the laboratory.The e602 module serial number was not provided.The serial number for the core unit that the module is associated with is (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8993119
• MDR Text Key: 206291018
• Report Number: 1823260-2019-03271
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• PMA/PMN Number: K001104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 31572404
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPART INSULIN
• Patient Age: 8 YR