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

Model Number 021-105

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

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Date 07/08/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient¿s daughter contacted lifescan (lfs), alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to their 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 (mss) after reviewing the call recording.The reporter stated that the alleged meter inaccuracy occurred at an unspecified time on (b)(6) 2022.The reporter claimed the patient obtained an inaccurate high result of ¿380 mg/dl¿ with the subject meter.During the call, the reporter informed the cca that the patient does not normally take any medication to manage their diabetes.The reporter stated that the patient had not used insulin for over 1 year; however, they took 25 units of insulin in response to the elevated result and 4 more units at night when their blood glucose still did not go down.The reporter claimed that the patient went to sleep and the following morning they found the patient in a "coma".The patient was taken to the emergency room (er) by ambulance and on arrival at er, their blood glucose measured ¿12 mg/dl¿ on the hospital meter.The reporter claimed the patient was given glucose and was discharged from hospital the following day.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the test strips were stored correct and were not expired or opened past their discard date.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 administering insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; gubelstrasse 34; malvern PA 19355
• MDR Report Key: 15089897
• MDR Text Key: 296463971
• Report Number: 2939301-2022-03067
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• 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
• Device Lot Number: 4768122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female