MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number	022-657
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Malaise (2359)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged inaccuracy issue began 1 week prior to contacting lfs; she was unable to recall the exact date and time.The patient reported obtaining a blood glucose reading of ¿300 mg/dl¿ with the subject meter and after more than 20 minutes, she remeasured obtaining a reading of "48 mg/dl." the patient stated that she manages her diabetes with insulin (novomix, twice daily) and oral medication (metformin, 2 pills).The patient denied making any changes to her usual diabetes management regimen due to the alleged issue.The patient reported developing symptoms of ¿dizziness and bad feeling¿ after the reading of ¿48 mg/dl" was obtained; she was unable recall exact time.The patient claimed she was treated by her daughter with dextrose.No other device was used for testing.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the same approved sample site was used for testing.The cca noted the test strips were in good condition.The cca noted 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 required assistance of a third party for treatment of an acute low blood glucose excursion after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12538100
• Report Number: 2939301-2021-02958
• Device Sequence Number: 16478036
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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): 09/27/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 022-657
• Device Catalogue Number: 022-657
• Device Lot Number: 4712034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention