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

Model Number	023-878
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Hypoglycemia (1912); Shaking/Tremors (2515)
Date of Event	01/14/2021
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 his onetouch verio reflect meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on (b)(6) 2021 at 6:12 pm.The patient reported obtaining an inaccurate high blood glucose reading of ¿122 mg/dl¿ with the subject.The patient manages his diabetes with a fixed dose of insulin (10 units daily after evening meal).The patient denied making any changes to his usual diabetes management regimen as a result of the alleged issue.The patient reported that 15 minutes after the alleged issue occurred , he developed symptoms of ¿eye pain like a migraine, weak and shaking;¿ symptoms he associated with hypoglycemia.The patient claimed he treated himself with sugar in response to the symptoms and felt better a few minutes afterwards.The patient denied using any other device to test his blood glucose.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.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 developed symptoms suggestive of a serious injury adverse event after the alleged product issue occurred.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO REFLECT METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11224147
• Report Number: 2939301-2021-02815
• Device Sequence Number: 11835799
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 01/15/2021

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: 023-878
• Device Lot Number: 4686906
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2021
• 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