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 Problems Hypoglycemia (1912); Diaphoresis (2452)

Event Date 08/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that her onetouch ultra2 meter read inaccurately high compared to another meter (doctor¿s meter; brand unspecified).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy first started on (b)(6) 2022, between 3:00 am and 6:00 am.The patient reported obtaining blood glucose readings of between ¿300 to 400 mg/dl¿ with the subject meter compared to ¿57 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient stated that she manages her diabetes with oral medication (glipizide 10mg) and took her usual dose of medication in response to the alleged issue.The patient reported developing symptom of ¿sweating¿ after the alleged issue began and proceeded to the emergency room (er) where her blood glucose measured ¿57 mg/dl¿ on the doctor¿s meter at 6:00 am.The patient stated she was at the er for 12 hours, was treated with orange juice and advised to schedule an appointment with her doctor.At the time of troubleshooting, the cca confirmed an approved sample site was used for testing.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 after obtaining alleged inaccurate high blood glucose readings with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 15263324
• MDR Text Key: 298283621
• Report Number: 2939301-2022-03086
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2022

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: 4777056
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention