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

Lot Number 4572216

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

Patient Problems Fainting (1847); Head Injury (1879); Sweating (2444)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On december 17, 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioflex meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer service agent (csa) documentation.It was not reported when the alleged inaccuracy issue began.The patient reported obtaining an alleged inaccurate high result of ¿451 mg/dl¿ with the subject meter.The patient manages her diabetes with humalog insulin (1-2 units), humulin 75/25 insulin and victoza 1.8 mg injection.The patient reported that before lunch on (b)(6) 2019, she took an unspecified dose of humulin 75/25 insulin in response to the alleged issue.The patient claimed that 4 hours after the meal, she developed symptoms of ¿cold sweats, could not speak, limbs getting numb and passed out on the bathroom floor.¿ the patient claimed she ¿hit her head¿ when she fell down.The patient stated that when her son found her unconscious at around 5:00 pm, he called 911 for assistance and reportedly measured her blood glucose at ¿30 mg/dl¿ with the subject device.He then gave her juice and a banana to stabilize her blood glucose.After treatment, the patient claimed she felt a lot better and her blood glucose was measured at ¿60 mg/dl¿ on the subject device.The patient claimed that after getting cleaned up, she was taken by ambulance to hospital.No further treatment was specified however the patient claimed that the following day, her doctor lowered her dose of insulin from 60 down to 30 units.At the time of troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter.The csa noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: michelle karim ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED ; 1463383679
• MDR Report Key: 9574207
• MDR Text Key: 175463052
• Report Number: 3008382007-2020-03838
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150214
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4572216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention