MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4510410

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Deafness (1801); High Blood Pressure/ Hypertension (1908); Hypothermia (1915); Seizures (2063); Loss of consciousness (2418); Shaking/Tremors (2515); No Code Available (3191)

Event Date 11/09/2019

Event Type  Injury  

Event Description

On november 9, 2019, a reporter for the patient (the patient¿s pharmacist) contacted lifescan (lfs) france, alleging that the patient¿s onetouch verio 2 meter displayed inaccurately high results.The complaint was classified based on the customer service representative (csr) documentation, after additional information was obtained directly from the patient during a follow-up call on (b)(6) 2019.The patient reported that she had obtained high readings on the subject meter for about a week prior to contacting lfs.She stated that at 00:10am on (b)(6) 2019, she tested her blood glucose level using the subject meter and obtained a result of ¿243 mg/dl¿, which, with hindsight, she considers to have been too high.The patient manages her diabetes with daily doses of 7 units of apidra and 20 units of levemir insulin.She denied making any changes to her usual diabetes management routine after obtaining the reported result.She stated that around 4am on (b)(6) 2019, she developed symptoms of ¿hypertension, hypothermia, eyesight issue, hearing issue, convulsions, trembling and a brief loss of consciousness¿ which she associated with hypoglycemia.She reported that the emergency medical services (ems) were contacted, and she received ems treatment of ¿food and/or drink¿, after which a blood glucose result of ¿120 mg/dl¿ was obtained on the ems meter.At the time of troubleshooting, the reporter confirmed that the subject meter was set to the correct unit of measure.The patient did not have control solution to test the meter and test strips and education on its use was provided by the csr.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event requiring ems intervention, after obtaining an alleged inaccurately high blood glucose result on the subject meter and continuing with her usual diabetes management routine.

• Brand Name: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 9321372
• MDR Text Key: 166732620
• Report Number: 2939301-2019-02531
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4510410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/09/2019
• 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