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

Model Number 021-105

Device Problem Failure to Calibrate (2440)

Patient Problems Vertigo (2134); Shaking/Tremors (2515)

Event Date 07/26/2021

Event Type  Injury  

Event Description

On july 26, 2021, 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 and on additional information obtained after the cca reviewed the call again.The patient alleged that the power issue started on (b)(6) 2021, at an unspecified time.The patient stated that she inserted the test strip correctly, but the subject meter would not power on.The patient usually manages her diabetes with oral medication (glipizide and metformin ¿ dosage unspecified) and claimed that on (b)(6) 2021, she skipped a dose of metformin because she was unable to obtain a reading on the subject meter.On (b)(6), 2021, approximately at 12:00 pm during the call with lfs, after the alleged issue occurred, the patient started to develop the symptom of ¿shaking¿.The cca offered to call back and about two hours later the patient reported that she had self-treated with food and stated that she felt better after eating.The patient specified that she ate her regular lunch and did not feel shaky anymore.After troubleshooting, the patient was able to power the meter on and obtained an unspecified blood glucose reading.The patient stated ¿yes, it is high, this is the reason why i was feeling dizzy¿.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.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12278309
• MDR Text Key: 265089410
• Report Number: 2939301-2021-02915
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• 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: 08/04/2021

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
• Device Lot Number: 4687465
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening