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

Lot Number	5770359
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Headache (1880); Dysphasia (2195); Lethargy (2560); Syncope/Fainting (4411); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 22, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio flex meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began around august 5, 2024.The patient claimed obtaining blood glucose readings of ¿108, 46 and 266 mg/dl¿ with the subject meter, performed within 20 minutes of each other.The patient manages her diabetes with a combination of diabetes medications (lantus insulin, 60 units; regular insulin, 50 units; ozempic, once weekly injection).It was not reported if the patient made any changes to her usual diabetes management regimen due to the alleged issue.The patient reported that on (b)(6) 2024, at 8:00 pm, she started having symptoms of ¿very sleepy, bad headache, lethargic, stop talking and pass out¿ and her neighbour called emergency medical services (ems) for assistance.The patient reported that at 8:30 pm, paramedics treated her with 2 bags of iv glucose and she ate a peanut butter sandwich and drank a coke.The patient claimed she received a blood glucose result of ¿261 mg/dl¿ on the ems meter at 9:30 pm.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the same approved sample site was used for testing and that the correct testing process was being followed.The cca confirmed the test strip vial was intact, and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to perform a quality control test.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 after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO FLEX METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 20082131
• Report Number: 2939301-2024-00064
• Device Sequence Number: 7810113
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 5770359
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown