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

Model Number 021-105

Device Problem Failure to Calibrate (2440)

Patient Problems Headache (1880); Vertigo (2134)

Event Date 09/27/2022

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.The patient alleged that the power issue started on (b)(6) 2022, at night.The patient stated that she felt her sugar levels went up and tried to test with the subject meter.The meter did not turn on after inserting a test strip and the patient started developing symptoms of ¿dizziness and headache¿.The patient manages her diabetes with diet and exercise only and denied that she took any action in response to the alleged issue.The patient went to the clinic due to having the symptoms, where she was treated by an hcp with oral medication (januvia) and with insulin shots.The patient did not report whether a blood glucose test was performed on another device.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 to the device.The patient had used the correct test strips and confirmed that the subject meter would power on by using the power button.The cca walked the patient through a retest with a new test strip and the meter did power on.The patient did not need a replacement meter as she was now able to receive a blood glucose reading.This complaint is being reported because the patient claims that she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms/signs suggestive of a serious injury adverse event after the alleged meter issue began.

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.An evaluation of the test strip lot was unable to be conducted as the lot number was not provided.

• 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: 15655934
• MDR Text Key: 302246460
• Report Number: 3009698388-2022-00056
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/21/2022
• 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): Life Threatening; Required Intervention
• Patient Sex: Female