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

Model Number 023-271

Device Problem Device Handling Problem (3265)

Patient Problems Fatigue (1849); Shaking/Tremors (2515); Decreased Appetite (4569)

Event Date 11/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio flex meter displayed inaccurately erratic blood glucose results compared to another meter.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the subject meter displayed inaccurate readings like ¿288, 213 and 265 mg/dl¿ since (b)(6) 2021.The patient informed the cca that on (b)(6) 2021, at 8:00 a.M.He obtained a blood glucose reading of ¿300 mg/dl¿ on the subject meter compared to a reading of ¿108 mg/dl¿ on a contour next ez meter, greater than 30 minutes apart from each other.The patient manages his diabetes with 1.5 units of trulicity and claimed that he increased his dose to 3 units of trulicity at 8:30 a.M.In response to the alleged issue.The patient stated that the following morning and afternoon (on (b)(6) 2021) he felt ¿a lack of appetite, tired, shaky and weak¿.The patient reported that he self-treated with glucose tablets to increase his glucose levels.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.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 trulicity based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12903551
• MDR Text Key: 281857064
• Report Number: 2939301-2021-02991
• 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: 11/30/2021

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: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4753386
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male