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

Model Number 022-659

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Vomiting (2144); Dizziness (2194); Abdominal Cramps (2543)

Event Date 10/18/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a reporter for the lay user/patient contacted lifescan (lfs) usa, alleging that the patient's onetouch verio2 meter was displaying an unknown error message.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter was unable to state when the alleged issue with the subject device began.The patient manages her diabetes with insulin (unspecified type or dose) and the reporter stated that the patient did not make any changes to her usual diabetes management regimen in response to the alleged issue.The reporter stated that on the morning of (b)(6) 2020, after the alleged issue with the subject device began, the patient began "throwing up", that her "stomach started hurting badly" and that she was "getting dizzy".The reporter advised that later that day (unknown time) they called an ambulance and that the patient was taken to the emergency room (e.R).On arrival at the er, the patient's blood glucose was reportedly measured at "600 mg/dl" on the hospital device and the reporter advised that she was subsequently treated by a healthcare professional (hcp) with iv fluids and antibiotics.The reporter stated that prior to leaving hospital on (b)(6) 2020, the patient's blood glucose was measured at "200 mg/dl" on the hospital device.At the time of troubleshooting, the cca established that the device was not being used for the first time.The cca walked the reporter through resolving the issue; however, noticed that the alleged issue remained unresolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event and required hcp treatment for an acute high blood glucose excursion after the alleged issue occurred.

• Brand Name: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10807754
• MDR Text Key: 215277217
• Report Number: 2939301-2020-02753
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• 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: 10/20/2020

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
• Device Model Number: 022-659
• Device Lot Number: 4576373
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR