OT DELICA LANCING DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for OT DELICA LANCING DEVICE manufactured by Lifescan Europe Gmbh.

Event Text Entries

[179320315] On january 30, 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that the lancets do not fully penetrate when using her onetouch delica lancing device. The complaint was classified based on information obtained from the customer service representative (csr) documentation the patient reported that the alleged issue with the subject lancing device began at an unknown time on (b)(6) 2020. The patient manages her diabetes with oral medication (metformin, 500 mg daily) and she denied making any changes to her usual diabetes management regimen in response to the alleged issue. The patient reported that at around 10 45 a. M. , on the morning on (b)(6) 2020, she developed symptoms of? Sweating and a headache?. It is not known if the patient received treatment as a result of the alleged issue. At the time of troubleshooting, the csr noted that the patient had begun using the subject device that day. The csr confirmed that the patient was using the correct lancets, noted that the lancet gauge was 33g and confirmed that there was no misuse of the device. The csr also reviewed the patient? S sample collection technique; however, noted that the alleged issue remained unresolved. A replacement product was sent to the patient. This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged issue with the subject device began.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2939301-2020-02583
• MDR Report Key: 9664700
• Date Received: 2020-02-04
• Date of Report: 2020-01-30
• Date of Event: 2020-01-30
• Date Facility Aware: 2020-01-30
• Date Added to Maude: 2020-02-04
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OT DELICA LANCING DEVICE
• Generic Name: GLUCOSE MONITORING SYS/KIT
• Product Code: FMK
• Date Received: 2020-02-04
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LIFESCAN EUROPE GMBH
• Manufacturer Address: GUBELSTRASSE 34 ZUG 6300 CH 6300

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-02-04
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2020-02-04