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

Device Problem Defective Component (2292)

Patient Problems Fatigue (1849); Vertigo (2134); Hot Flashes/Flushes (2153)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch delica lancing device was damaged.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged lancing device issue began on (b)(6) 2019 at 7am.The patient claimed that her lancet holder was damaged.The patient informed the csr that she manages her diabetes with metformin twice daily and insulin(type unspecified); "165 units in the morning and 135 units in the evening".The patient reported that 5 minutes after the alleged lancing device issue began she just took her usual medication of "165 units of insulin".The patient claimed that on the same day at 7:30am she developed symptoms of ¿hot flashes, felt tired and out of balance¿.The patient denied receiving any treatment or medical intervention for her symptoms.During troubleshooting, the csr confirmed that the device was not being used for the first time and that the device had been in use for 2 years.The csr noted that the patient was using the correct lancets for her device and based on the information provided there was no misuse to the device.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged lancing device issue began.

• Brand Name: OT DELICA LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8334335
• MDR Text Key: 135996092
• Report Number: 3008382007-2019-00417
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2019

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: 01/31/2019
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/13/2019
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1