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

Lot Number 3586665

Device Problem Device Alarm System (1012)

Patient Problems Dyspnea (1816); Shaking/Tremors (2515)

Event Date 09/11/2020

Event Type  Injury  

Event Description

On september 12, 2020, the patient contacted lifescan (lfs) usa, alleging that their onetouch ultramini meter was displaying a "strip blinking" message.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter message began to appear on (b)(6) 2020, "around 19:00" and they were unable to obtain a blood glucose reading.The patient stated that they manage their diabetes with oral medication twice a day but did not specify which medication(s) or dosage(s) but no changes were made to their usual diabetes management regimen in response to the alleged issue.The patient stated that they were "feeling bad" when they tried to perform a blood glucose test.After this they "started shaking" and "couldn't breathe well".In response to the symptoms, the patient had to go to the emergency room where a blood glucose test was performed on a hospital meter and a reading of "60 mg/dl" was obtained.The hcp then provided the patient with a drink (apple juice) as treatment.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time and there was no indication of misuse to the device.Replacement products were sent to the patient.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event requiring medical intervention after the alleged meter issue began.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10618786
• MDR Text Key: 209561522
• Report Number: 2939301-2020-02727
• Device Sequence Number: 1
• Product Code: NBW
• 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: 09/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3586665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2020
• 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: 52 YR