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); Hypoglycemia (1912); Twitching (2172); Shaking/Tremors (2515)

Event Date 11/15/2020

Event Type  Injury  

Event Description

On november 16, 2020, a reporter for the lay-user/patient contacted lifescan (lfs) usa, alleging that the patient's onetouch ultra2 meter was reading inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred on (b)(6) 2020 at 4:00 am.The reporter claimed the patient obtained blood glucose readings of "500, 473 and 487 mg/dl" with the subject meter, performed within 20 minutes of each other.The patient is on insulin pump therapy.In response to the alleged inaccurate results, the reporter claimed she gave the patient 3.5 units of insulin at 4:00 am.The reporter claimed that a couple of hours after the insulin was administered, the patient developed symptoms of "legs shaky, could not stand and twitching as if he was going into a seizure." at the onset of the symptoms, the patient's blood glucose was tested on another meter (verio) and a result of "46 mg/dl" was obtained.The reporter claimed she treated the patient with "black pepper" and "tried to continuously take the insulin out of the patient's body." the reporter denied the patient received any medical intervention as a result of the alleged issue.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 confirmed the test strip vial was intact and that the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to test the subject meter.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 insulin was administered based on alleged inaccurate readings obtained with the subject meter.

• 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: 10965922
• MDR Text Key: 220246248
• Report Number: 2939301-2020-02772
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• 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: 11/16/2020

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening