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

Model Number	022-659
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio2 meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on further information obtained by the medical surveillance specialist after reviewing the call recording.The patient reported that the alleged meter inaccuracy began 3 weeks prior to contacting lfs.The patient reported obtaining what they felt were inaccurate high blood glucose readings of ¿145, 120, 80, 109, 108, 110, 134 and 147 mg/dl¿ with the subject meter on unspecified dates/times.The patient manages their diabetes with oral medication (metformin) and they continued to follow their usual diabetes management regimen in response to the alleged issue.The patient reported that on (b)(6) 2022, between 12:30 and 1:00 pm, they experienced a ¿low sugar¿ with symptoms of ¿sweating and shaking¿.The patient claimed they self-treated with orange juice.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.The cca confirmed the test strip vial was intact and the test strips had been stored correct and were not expired or opened past their discard date.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 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: 15442741
• Report Number: 2939301-2022-03098
• Device Sequence Number: 5582425
• 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): 09/16/2022

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: 022-659
• Device Lot Number: 4857083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2022
• 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