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

Device Problem Defective Component (2292)

Patient Problem Hypoglycemia (1912)

Event Date 11/14/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch delica plus lancing device has a loose cap.The complaint was classified based on the customer care agent (cca) documentation of the initial call.The patient reported that she obtained the subject device around six months prior to the call with lfs, and the alleged issue started at the same time.The patient claims that she could not use the subject lancing device with the top cap because it loosened and therefore used it without the cap to prick her fingers.The patient stated that it was too painful to use and for this reason she could not get a blood sample.The patient manages her diabetes with novolin r (injection 2 times per day, (b)(4) units in the morning and (b)(4) units in the evening) and she did not specify whether she made any changes to her usual diabetes management regimen in response to the alleged issue.On (b)(6) 2023, at an unspecified time, the patient was unable to test due to the alleged issue and had ¿very low sugar¿.The patient called an ambulance and was brought to a hospital where she was treated with a liquid glucose injection by a health care professional (hcp).The patient mentioned that at the hospital blood glucose readings of ¿40 and 65 mg/dl¿ were obtained on a hospital meter.During troubleshooting, the cca established that the subject device was not being used for the first time and that the patient had used the correct lancets (gauge 33g) and the correct cap.A replacement lancing device was sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged lancing device issue began.

Manufacturer Narrative

- correction to date in b5.Field: "on november 29, 2023, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch delica plus lancing device has a loose cap." - correction to d3.Field: asahi polyslider company limited.860-2 misaki, maniwa, okayama japan 719-3226.

• Brand Name: OT DELICA PLUS LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 18309170
• MDR Text Key: 330223989
• Report Number: 2939301-2023-00104
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female