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

Lot Number	5631730
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Hypoglycemia (1912); Diaphoresis (2452); Presyncope (4410)
Date of Event	12/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2023, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained when the medical surveillance specialist reviewed the call recording.During the call, the patient was unable to confirm when the alleged meter inaccuracy began.The patient stated that she manages her diabetes with oral medication (metformin 500 mg once daily).She did not report making any changes to her normal diabetes management regimen due to the alleged issue.On (b)(6), 2023, at 11:38 am, the patient claimed she woke up with hypoglycemic symptoms described as ¿sweaty, weak and felt like passing out.¿ in response to the symptoms, the patient stated that she tested her blood glucose with the subject meter and obtained back-to-back results of ¿545, 229, 217 mg/dl.¿.The tests were taken within 3 minutes of each other.The patient stated that she sat for a while and treated herself with food (peanut butter and crackers) at 11:45 am, shortly after taking the tests.The patient did not use any other device to test her blood glucose.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca determined that the same approved sample site was used for testing and that the correct testing process was being followed.The cca confirmed that the test strips were in good condition.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 while using the product.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; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 18343347
• Report Number: 2939301-2023-00110
• Device Sequence Number: 12868127
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• 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): 12/18/2023

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 5631730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2023
• 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: Life Threatening
• Patient Sex: Unknown