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

Lot Number	5736513
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the lay-user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra2 meter does not turn on.The complaint was classified based on the customer care agent (cca) documentation, on review of the call recording and on additional information obtained during a follow up call with the patient.The patient reported that the alleged issue started two days prior to the call with lfs, at an unspecified date.The patient manages their diabetes with a combination of medication (humalog insulin and toujeo insulin ¿ dose unspecified) and claimed that they increased their humalog insulin by 7 units and their toujeo insulin by 5 units in response to the alleged issue.The patient denied developing any symptoms due to the alleged issue, however, the patient stated that they went to the emergency room (er) after they obtained a blood glucose reading of ¿480 mg/dl¿ on the subject meter, two days prior to the call with lfs.During follow up, the patient confirmed that they were treated by a health care professional (hcp) with humalog insulin twice and an unspecified long-acting insulin.Before and after treatment unspecified blood glucose readings were obtained at the er.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and there was no indication of misuse of the device.The subject meter did not turn on by pressing the power button nor by inserting a new test strip.The meter does have replaceable batteries, but the cca established that they did not need replacing.Replacement products were sent to the patient.This complaint is being reported because the patient claimed they were unable to test their blood glucose due to the reported issue, increased their diabetes medication in response and reportedly received medical intervention at the er for an acute high blood glucose excursion.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 20563823
• Report Number: 2939301-2024-00077
• Device Sequence Number: 15278195
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• 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): 10/29/2024

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 Lot Number: 5736513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown