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

Model Number 022-275

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Paresis (1998); Presyncope (4410)

Event Date 12/01/2021

Event Type  Injury  

Event Description

On december 2, 2021, the patient/lay user contacted lifescan (lfs) usa alleging that his onetouch verio iq meter read inaccurately high compared to his feelings and/or normal results.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged issue began on (b)(6) 2021, in the evening.The patient claimed obtaining a blood glucose reading of ¿80 mg/dl¿ with the subject meter and indicated that after the reading he ¿had a faint, could not move¿ and had to call for help.Within 30 minutes the paramedics arrived and they obtained a blood glucose reading of ¿43 mg/dl¿ on an emergency medical services (ems) meter.The patient manages his diabetes with diet and exercise and claimed that he did not make any changes to his usual diabetes management regimen in response to the alleged issue.The patient informed the cca that he was treated by an hcp with a glucose injection.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter, the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.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 and because the patient reportedly received hcp treatment for an acute low blood glucose excursion after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO IQ METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 13031082
• MDR Text Key: 286655834
• Report Number: 2939301-2021-02998
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022-275
• Device Catalogue Number: 022-275
• Device Lot Number: 4762937
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 66 YR