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 Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 05/07/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was reading inaccurately erratic.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call.The patient reported that the alleged inaccuracy issue first began at 7:30 a.M., on (b)(6) 2023, when the patient claimed obtaining a blood glucose reading of ¿185 mg/dl¿.The patient also claimed obtaining additional blood glucose readings of ¿66, 139, 77, 166 and 180 mg/dl¿ with the subject device, performed at an unspecified time, more than 20 minutes apart.The patient advised that their usual blood glucose results range between 125-130 mg/dl.The patient manages their diabetes with oral medication (metformin, 1 mg, twice daily), diet and exercise and it is not known if the patient made any changes to their usual diabetes management regimen in response to the alleged inaccuracy issue.The patient reported that an unspecified time after obtaining the blood glucose reading of ¿185 mg/dl¿, they developed symptoms of feeling ¿shaky¿ and that they were ¿sweating¿.The patient reportedly self-treated their symptoms by drinking a ¿bottle of coke¿ and advised the cca that they went to lay down at 10:30 a.M., for 2 hours until they felt better.At the time of troubleshooting, the cca confirmed that an approved sample site was used to obtain the readings.The cca also noted that at the time of the call, the patient did not have control solution available to complete a quality control test with 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 for an acute low blood glucose excursion after the alleged issue with the subject device began.

• 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: 17029664
• MDR Text Key: 316235364
• Report Number: 2939301-2023-00031
• 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: 05/31/2023

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
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 5641177
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• 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