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

Model Number INSULIN

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The customer confirmed system maintenance was performed regularly.Also, the measuring cell was new, and the pipetting system, mixer unit, pinch valve tubings were controlled and looked good.The patient's sample was requested for an investigation, but the sample was not available.The investigation did not identify a product problem.  a general instrument or reagent problem could be identified.The cause of the event could not be determined. .

Event Description

The initial reporter received questionable elecsys insulin results for one patient tested on a cobas e411 rack with a serial number (b)(4).The customer confirmed qc was acceptable.The patient's initial insulin result was not reported outside the laboratory.The customer performed repeat measurements on the same analyzer as well as a cobas 8000 e 801 module located at a different laboratory.On (b)(6) 2021 and at 11:38, the patient's initial insulin result was 0.200 uu/ml with a data flag.At 12:08, the patient's first repeat result on the e411 rack was 0.200 uu/ml with a data flag.At 16:00, the patient's second repeat result on an e 801 module was 1.20 uu/ml.On (b)(6) 2021, the patient's third repeat result on the e411 rack was 0.200 uu/ml with a data flag.The customer reported the patient's insulin result of 1.20 uu/ml outside the laboratory.

• Brand Name: ELECSYS INSULIN
• Type of Device: 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: 11672428
• MDR Text Key: 246271563
• Report Number: 1823260-2021-01147
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K001104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: INSULIN
• Device Catalogue Number: 12017547122
• Device Lot Number: 47675203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1