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

Device Problem Device Handling Problem (3265)

Patient Problems Dizziness (2194); Syncope/Fainting (4411)

Event Date 05/26/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the reporter (the niece) of the lay user/patient contacted lifescan (lfs) france, alleging that the patients onetouch verio 2 meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter alleged that the issue started on (b)(6) 2023, at an unspecified time in the afternoon when the patient received a blood glucose reading of ¿310 mg/dl¿ on the subject meter.Less than 30 minutes later, the patient compared the reading to a blood glucose reading of ¿165 mg/dl¿ which she obtained on a contour plus meter.The patient manages her diabetes with a combination of medication (novo rapid insulin ¿ 8 units three times a day, abasaglar insulin ¿ 25 units in the evening, metformin 500 mg ¿ 1 pill in the afternoon, pravastatine 20 mg ¿ 1 pill in the evening, galvus 50 mg ¿ 1 pill twice a day) and the reporter claimed that she increased her abasaglar insulin with an extra dose in the evening on (b)(6) 2023, in response to the alleged issue.The reporter stated that the patient started feeling ¿dizzy and fainted¿ after the issue occurred on (b)(6) 2023, in the afternoon.The reporter informed the cca that the patient was transported to the hospital for unspecified medical treatment by an hcp on (b)(6) 2023, in the afternoon.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had used an approved sample site to obtain the blood samples.However, the cca established that the patient was not following the correct testing procedure by applying the same blood sample on both tests without washing her hands.The cca noted that the patient did not have control solution at the time of the call to test the subject system.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 after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 17093363
• MDR Text Key: 316846862
• Report Number: 3008382007-2023-00031
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Hospitalization
• Patient Sex: Female