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

Lot Number 5671344

Device Problem Battery Problem (2885)

Patient Problems Malaise (2359); Balance Problems (4401); Presyncope (4410)

Event Date 01/01/2024

Event Type  Injury  

Event Description

On january 1, 2024, lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verio flex meter was continually displaying the battery indicator, preventing testing.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call and additional information obtained when the cca listened to the call recording.The patient reported that the alleged meter issue began on an unspecified date approximately one week prior to contacting lfs.The patient reported that on january 01, 2024 at around 10:25 a.M., prior to attempting to test their blood glucose, they developed symptoms of feeling ¿funny, weak, terrible¿ and that they felt like they ¿would fall down¿ which they associated with a low blood glucose excursion.The patient reported that they were unable to obtain a blood glucose reading due to the battery indicator issue and in response to the symptoms, they immediately self-treated by drinking some pineapple juice and then went and laid down before calling lfs at approximately 10:30 a.M., the same day.The patient manages their diabetes with a combination of insulin (lantus, 40 units and humalog, 10 units) and oral medication (janumet, 450 mg, two tablets twice daily).At the time of troubleshooting, the cca established that the device was not being used for the first time and noted that there was no apparent misuse of the device.The cca confirmed that the battery icon did not only occur on the start-up screen and that based on the information provided, the meters batteries did need replacing as the patient had not changed the batteries in over a year.The cca noted that the patient did not have replacement batteries available.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms which may be indicative of a serious injury adverse event for an acute low blood glucose excursion and the alleged battery indicator issue with the subject meter could not be ruled out as a cause and/or contributor to the reported event.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 18542320
• MDR Text Key: 333228590
• Report Number: 2939301-2024-00006
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5671344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening