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

Device Problem Defective Component (2292)

Patient Problems Fatigue (1849); Dysphasia (2195)

Event Date 06/04/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the reporter (wife) for the lay user/patient contacted lifescan (lfs) usa, alleging his onetouch mini lancing device had a damaged lancet holder.This complaint was classified based on the information obtained from the customer care agent (cca) during the initial call and additional information obtained when the medical surveillance specialist (mss) reviewed the original call recording.The reporter stated that the alleged issue began on (b)(6) 2021, at 7:00am.The patient manages his diabetes non adjusted insulin, ¿basaglar, 20 units in the morning and 18 units at night¿ and made no change to his usual diabetes regimen in response to the alleged issue.The reporter advised that at 7:00am on (b)(6) 2021, before the alleged issue began, the reporter thought the patient was having a stroke as he had developed the symptoms of ¿unable to stand from his chair and was babbling¿.The reporter stated that she attempted to test his blood and discovered the issue with the lancing device.She reported that she called paramedics.Upon their arrival, they tested the patient and obtained a blood glucose result of 50mg/dl on a onetouch ultra meter.The hcp then advised the patient to take ¿orange juice, lunchmeat, bread and cheese¿.At the time of troubleshooting, the cca confirmed that the product was not being used for the first time and had been in use for ¿five years¿, the reporter was unable to confirm if the correct lancets were being used, based on the information provided, there was no misuse of the product.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event for an acute low blood glucose excursion in response to being unable to obtain a blood glucose reading, resulting in a potential delay in treatment.The alleged lancing device issue could not be ruled out as a cause and/or contributor to the event.

Manufacturer Narrative

This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11980127
• MDR Text Key: 255665141
• Report Number: 3008382007-2021-04165
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

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
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening