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 Code	Syncope/Fainting (4411)
Date of Event	08/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.
Event or Problem Description
On (b)(6) 2021, the lay-user/patient¿s son (the reporter) contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio iq meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the reporter.The cca was advised by the reporter that on (b)(6) 2021 at 11:30 pm, the patient obtained an alleged inaccurate high blood glucose reading of between ¿190 to 220 mg/dl¿ with the subject meter.The patient manages his diabetes with humulin 70/30 insulin on a self-adjusting dose.The reporter claimed that in response to the alleged issue, the patient took an unspecified dose of insulin to lower his blood glucose then patient ¿fainted.¿ during the follow-up call, the reporter claimed the patient was unconscious for between 10-15 minutes.The reporter claimed the patient was treated by emergency medical services (ems) with ¿serum¿ and with ¿liquid¿ that they administered slowly; exact details were unable to be provided.The reporter stated that the patient¿s blood glucose was measured with the ems meter until he stabilized however exact readings were unable to be provided.During the follow-up call, the reporter claimed that prior to the incident, the patient¿s doctor had made changes to the patient¿s diet to help him lose weight; he was advised to have a diet of vegetables and healthy food, to avoid eating lots of carbohydrate and meat.During the follow-up call, the reporter attributed the patient¿s drop in glucose levels to the dose of insulin that he took.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 product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after administering insulin based on an alleged inaccurate high result obtained with the subject meter.

• 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: 12465427
• Report Number: 3008382007-2021-04226
• Device Sequence Number: 4738708
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): Y
• PMA/510(K) Number: K110637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 022-275
• Device Catalogue Number: 022-275
• Device Lot Number: 4463630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/13/2021
• 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