MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT DELICA PLUS LANCING DEVICE; GLUCOSE MONITORING SYS/KIT

Device Problem Defective Component (2292)

Patient Problems Dizziness (2194); Diaphoresis (2452); Confusion/ Disorientation (2553); Alteration in Body Temperature (4568)

Event Date 03/31/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the reporter called lifescan (lfs) us on behalf of the patient alleging that they were having difficulty using the ot delica plus lancing device and lancets.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged issue began in (b)(6) 2020 (no exact date was given).They reported that the small size of the device and individual lancets combined with the patient¿s decreasing dexterity meant that they were unable to use the device.As a result of this, the patient had not been testing regularly and had experienced some high and low blood glucose excursions.On the evening of (b)(6) 2021, the patient called for emergency medical services (ems) for help as they felt ¿disoriented, dizzy, cold and clammy¿.The ems tested the patient¿s blood glucose on the patient¿s device and obtained a reading of ¿64 mg/dl¿.The patient manages their diabetes with levemir insulin (self-adjuster) and metformin however the reporter did not have any further details.The patient was treated with fruit juice to raise their blood glucose.The patient had to call the ems on the evening of (b)(6) 2021 however no details about this incident were given.During troubleshooting, the patient confirmed that the correct lancets were being used and there was no misuse of the product.A replacement device was sent to the patient.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged lancing device issue began.

• Brand Name: OT DELICA PLUS LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11744198
• MDR Text Key: 247911540
• Report Number: 2939301-2021-02855
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention