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

Model Number INSULIN

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

The assay had not been calibrated for one year and no quality control was performed on the day of the event.This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys insulin results for one patient from cobas e411 disk analyzer serial number (b)(4).On (b)(6) 2019, the result was 24.3 uu/ml.After two months of treatment with metformin, another sample was drawn from the patient.On (b)(6) 2019, the result was 43.69 uu/ml.On (b)(6) 2019, this sample was repeated on a beckmann coulter access ii analyzer at another site and the result was 29.0 uu/ml.On (b)(6) 2019, another sample was drawn from the patient and the result from the cobas e411 was 29.78 uu/ml.The sample was repeated on the access ii analyzer at another site and the result was 18.7 uu/ml.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

There was not enough sample volume left to complete the investigation.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: 8789871
• MDR Text Key: 151019147
• Report Number: 1823260-2019-02600
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 2017547214
• Device Lot Number: 315724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR