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	Hypoglycemia (1912)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging his onetouch verio iq meter read inaccurately high compared to his feelings and/or normal results.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and supplementary information obtained when the call recording was reviewed by the medical surveillance specialist (mss).The cca attempted to follow up at ms request, however, was unable to reach the patient by phone.The patient did not specify when the alleged issue started, however stated that he sometimes receives blood glucose readings of ¿300 or 400 mg/dl¿.The patient then retests, and the second reading is usually closer to how he feels.During the call, the patient mentions that at an unspecified date and time he received a blood glucose reading of ¿269 mg/dl¿ with the subject meter.The patient informed the cca that he usually manages his diabetes with insulin (twice a day ¿ type unspecified) and claimed on the call that he administered a higher dose of fast acting insulin than usual based on the meter reading.At an unspecified time after the alleged issue the patient developed symptoms of a ¿low blood sugar attack¿.The patient stated that he always carries a piece of candy with him and ate that to relieve the symptoms.No other blood glucose readings or further treatment was reported.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the patient did not have a control solution available to test the subject device.During review of the call, the mss noted that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The patient had also followed a correct testing method.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 taking an increased dose of insulin based on alleged inaccurate high results 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: 12046780
• Report Number: 2939301-2021-02884
• Device Sequence Number: 3503364
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): Y
• 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): 06/22/2021

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: 4697602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2021
• 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