MAUDE Adverse Event Report: LIFESCAN INC. OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

Device Problem Device Handling Problem (3265)

Patient Problem Loss of consciousness (2418)

Event Date 03/17/2022

Event Type  Injury  

Event Description

On march 17, 2022, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after the medical surveillance specialist (mss) reviewed the call recording.The patient indicated during the call with lfs that the subject meter has been giving allegedly inaccurate high readings for over 6 months.The patient claimed obtaining a blood glucose reading of ¿157 and 165 mg/dl¿ with the subject meter compared to ¿98 mg/dl¿ on a doctor¿s meter, within 20 minutes from each other.The patient has type 1 diabetes and manages his diabetes with insulin (humalog and levemir ¿ 4 to 5 shots per day) and he tests his blood glucose approximately 6 times per day.The patient claimed that due to the alleged issue, at an unspecified date and time, he increased his dose of insulin based on the subject meter¿s readings.The patient reported that after the adjusted dose of medication, he lost his balance and ¿passed out¿.According to the doctor the patient¿s blood glucose at that time was in the ¿high 20¿s, low 30¿s¿.The patient did not report if he received any medical treatment for the reported symptom.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and that the patient was following the correct testing procedure.The cca established that the patient had used an approved sample site to obtain his blood samples, however the test strips were beyond their expiry date.The cca noted that the patient did not have control solution at the time of the call to test the subject system.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 ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern PA 19355
• MDR Report Key: 13972226
• MDR Text Key: 288367077
• Report Number: 2939301-2022-03025
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• 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: 03/31/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4654254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening