MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONE TOUCH VERIO FLEX METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4511809

Device Problem Loss of Power (1475)

Patient Problems Fainting (1847); Bone Fracture(s) (1870); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioflex meter would not power on.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that she had the meter for about 3 months, and it had stopped powering on at 4pm on (b)(6) 2019; she reported that she was unable to obtain a result.The patient manages her diabetes with daily humalog insulin (sliding scale), 30 units of lantus insulin at night and weekly bydureon injectable medication.She reported that at 4pm on (b)(6) 2019, she administered 6 units of humalog.She indicated that because she was unable to test, she felt "very shaky and passed out twice" shortly after 4pm and at 11:30pm on (b)(6) 2019.She indicated that because she had passed out, she fell and broke her leg.She stated that on (b)(6) 2019, she had to had to go to her foot doctor who wrapped and taped her foot in a boot.At the time of troubleshooting, the cca noted that the meter was not being used for the first time and based on the information provided there was no misuse of the product.The meter would not turn on when the power button was pressed.Based on the information provided, the meter's battery did not need to be replaced.The cca walked the patient through inserting a new test strip into the meter per owner's manual, but the meter still did not turn on.The issue could not be resolved with training.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms that meet lfs' criteria for a serious injury adverse event, after the meter stopped powering on and she had continued to administer insulin.

• Brand Name: ONE TOUCH VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 8802074
• MDR Text Key: 151418581
• Report Number: 2939301-2019-02394
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• 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
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4511809
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2019
• Distributor Facility Aware Date: 07/10/2019
• Event Location: Home
• Date Report to Manufacturer: 07/10/2019
• 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