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

Model Number 021-105

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fatigue (1849); Dizziness (2194); Confusion/ Disorientation (2553); Presyncope (4410); Increased Appetite (4570)

Event Date 10/31/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter read inaccurately erratic and inaccurate compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording.The patient reported that towards the end of (b)(6) 2020, she began to obtain inaccurate readings always in the morning between 5:30 am to 7:00 am.The patient reported obtaining blood glucose readings of "137, 239, 137 and 137 mg/dl" with the subject meter, performed more than 20 minutes apart.The patient also reported obtaining what she felt were inaccurate results of "239, 137, 143, 215, 174, 126, 139, 120, 91, 137, 116, 110 and 137 mg/dl" with the subject meter.The patient stated that she manages her diabetes with oral medication (glimepiride 2 mg) and denied making any changes to her usual diabetes management regimen as a result of the alleged issue.During the call, the patient reported that up until the week prior to contacting lfs, she experienced intermittent episodes between 10:30 am to 11:30 am of feeling "faint, feeling like passing out, feeling like she needed something to eat, weak and out of it." the patient reported testing her blood glucose with the subject meter at the onset of symptoms and obtaining a "low" result (exact reading not provided).In response to the symptoms, the patient claimed she treated herself with food and drink and the symptoms resolved.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca documented that the same approved sample site was used for testing and that the correct testing process was being followed.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.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 EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11062526
• MDR Text Key: 223386260
• Report Number: 2939301-2020-02792
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Device Lot Number: 4553053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening