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

Model Number 021-105

Device Problem Loss of Power (1475)

Patient Problems Collapse (2416); Coma (2417)

Event Date 10/15/2019

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) canada, alleging that her onetouch ultra2 meter would not power on.The complaint was classified based on the customer service agent (csa) documentation.The patient claimed the alleged power issue occurred on (b)(6) 2019.She reportedly did not have replacement batteries at the time of the alleged issue.The patient manages her diabetes with humulin n and humulin r insulin (dosage not reported).It was not reported what changes were made to her usual diabetes management regimen when she was unable to perform a blood glucose test due to the alleged issue.The patient reported that on (b)(6) 2019, after the alleged issue began, she arrived home exhausted after driving from the states and went straight to bed.The following morning, she reportedly ¿collapsed and fell into a diabetic coma.¿ the patient claimed she was rushed to hospital but was unable to recall further details.At the time of troubleshooting, the csa noted the subject meter was not being used for the first time and there was no indication of misuse to the device.The csa noted that the correct test strips were being used for testing and based on the information provided, the batteries needed replacing.The csa noted the patient no longer had the products available to walk through resolving the issue and she declined to have them replaced.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 signs/symptoms suggestive of a serious injury adverse event requiring medical intervention after the alleged meter issue began.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 9976178
• MDR Text Key: 191269225
• Report Number: 2939301-2020-02620
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66