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

Model Number	022-275
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Syncope/Fainting (4411)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the lay user/patient contacted lifescan (lfs), alleging that their onetouch verio iq meter read inaccurately high compared to a laboratory method.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call recording.The patient reported that the alleged meter inaccuracy began at lunchtime on (b)(6) 2023 when they obtained an unspecified reading with the subject meter.The patient manages their diabetes with a set dose of insulin (humalog, three times a day before meals; humulin, morning and night).The patient denied making any changes to their usual diabetes management regimen as a result of the alleged issue.The patient claimed that around 4 hours after the alleged issue began, their ¿sugar dropped¿ while at the hospital for an appointment, and they ¿passed out¿ and got an ¿arm and head contusion¿.As a result, the patient reported that they were treated by a nurse with sugar and juice then hospitalized for more tests.After receiving treatment, the patient claimed they received a blood glucose lab result of ¿84 mg/dl¿ compared to the subject meter result of ¿156 mg/dl¿.The tests were performed within 10 minutes of each other.The patient was discharged from hospital that same day.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted an approved sample site was used for testing and 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 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 requiring medical intervention 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 IQ METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 17027824
• Report Number: 2939301-2023-00030
• Device Sequence Number: 6908656
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• 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): 05/30/2023

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 Model Number: 022-275
• Device Catalogue Number: 022-275
• Device Lot Number: 5592196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2023
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown