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 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer collected negative mixed serum samples and performed dilution tests for troubleshooting purposes.The insulin results for these samples were approximately 4.3 uu/ml and were diluted 20, 40 and 80 times respectively with the following results: 194.6 uu/ml (calculated result 3892 uu/ml), 115.1 uu/ml (calculated result 4604 uu/ml) and 56.99 uu/ml (calculated result 4559.2 uu/ml).The customer concluded there were endogenous interfering substances in the samples resulting in non-specific binding of the reaction process affecting the insulin results.The investigation is ongoing.

Event Description

The initial reporter questioned a high result not corresponding to the clinical picture for 1 patient sample tested for elecsys insulin (insulin) on a cobas 6000 e 601 module.The insulin result was > 1000 uu/ml.This result was reported outside of the laboratory.The patient's c-peptide result was normal at 1.02 nmol/l.The customer also checked other results from the patient: free-kap was 40.200 mg/l and free lam was 1090.000 mg/l.These results are used in the clinical diagnosis and monitoring of multiple myeloma.The customer suspects an interference in the patient sample affecting the insulin results based on the high free-kap and free lam results.The e601 module serial number was (b)(4).

Manufacturer Narrative

Based on the calibration and qc data provided, a general reagent issue is excluded.The alarm trace from (b)(6)2019 shows several messages related to sample quality.There was no sample available for further 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: 9197098
• MDR Text Key: 217924198
• Report Number: 1823260-2019-03746
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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: 315724
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR