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

Model Number 021-105

Device Problem Loss of Power (1475)

Patient Problems Visual Impairment (2138); Shaking/Tremors (2515)

Event Date 04/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter would not power on after inserting a test strip.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained after the medical surveillance specialist (mss) reviewed the call recording.The patient alleged that the power issue started on (b)(6) 2022, in the morning.The patient stated that she inserted the test strip correctly, but the subject meter would not power on.The patient informed the agent that she has type 2 diabetes and manages it with pills and insulin.The patient indicated that she usually tests six times a day and takes four times a day insulin.The patient did not specify whether she made any changes in response to the alleged issue.After reviewing the call recording the mss established that the patient stated that at the time of the call, after the alleged issue occurred, she felt ¿shaky¿ and indicated that her sugar is high and therefore it is ¿hard to see¿ the serial number of the meter.Customer care (cc) followed up with the patient and the patient reported that after the initial call she went to the doctor who treated her with one extra dose of her insulin.The patient did not specify if any other device was used to measure her blood glucose, however during troubleshooting it was established that the meter memory showed that the last reading was taken on (b)(6) 2022 and was ¿403 mg/dl¿.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and that there was no indication of misuse to the device.The cca documented that the correct test strips were being used for testing.The cca confirmed that the patient was able to turn the meter on manually when the power button was pressed.However, the meter did not turn on when the patient inserted the test strips.The cca concluded that the batteries did not need replacement.A replacement meter was sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms of a serious injury adverse event and received hcp treatment for an acute high blood glucose excursion while using the product.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 pkwy; malvern PA 19355
• MDR Report Key: 14283294
• MDR Text Key: 294263166
• Report Number: 2939301-2022-03032
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 4785540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2022
• 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 Sex: Female