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 Dehydration (1807); Dizziness (2194); Shaking/Tremors (2515); Presyncope (4410)

Event Date 10/31/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was displaying inaccurate readings.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the subject meter started reading inaccurate on (b)(6) 2022 at 11:53 pm.The patient obtained a blood glucose reading of ¿109 mg/dl¿ on the subject meter.The patient also reported blood glucose readings of ¿102 mg/dl¿ on (b)(6) 2022 and ¿119 mg/dl¿ on (b)(6) 2022 with the subject meter.The patient manages her diabetes with metformin pills (dosage unspecified) and she claimed that she drank a lot of water, ate a yogurt and drank some milk in response to the reading of (b)(6) 2022 at 11:55 pm.The patient stated that at that same time, after the alleged issue occurred, she developed symptoms of ¿dizzy, dehydration, feels out of herself, shaking¿ and ¿felt she was going to pass out¿.The patient indicated that she drank more water however, she denied receiving any medical treatment for the reported symptoms.During troubleshooting, the cca confirmed that 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 signs/symptoms suggestive of a serious injury adverse event while using the product.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 ; SZ 6300
• MDR Report Key: 15802112
• MDR Text Key: 303704711
• Report Number: 2939301-2022-03122
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 4728576
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2022
• 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: Female