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 Hypoglycemia (1912); Visual Impairment (2138); Confusion/ Disorientation (2553)

Event Date 05/24/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 meter did not power on.The complaint was classified based on the customer care agent (cca) documentation, since the patient was unable to be reached by phone for additional information.It was not reported when the alleged power issue began.It was not reported if the patient takes any medication to manage their diabetes or if they made any changes to their usual diabetes management regimen due to the alleged issue.However, the patient reported experiencing a low blood sugar with symptoms of feeling ¿disorientated and dark vision¿ although it is unknown if the symptoms began before or after the alleged issue started.In response to the symptoms, the patient reported attending the emergency room for treatment.It was not specified what treatment the patient received.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.The cca noted the meter would not power on manually when the power button was pressed.The cca documented that based on the information provided, the batteries did not needed replacing.Replacement product was made available to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 14607330
• MDR Text Key: 293447098
• Report Number: 3009698388-2022-00022
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening