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 Problem Fainting (1847)

Event Date 07/29/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter read inaccurate compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained when the medical surveillance specialist reviewed the call recording.The patient reported that on (b)(6) 2020 at around 8:00 pm, he obtained an alleged inaccurate reading with the subject meter.The patient was unable to recall the exact result obtained.The patient informed the cca that he manages his diabetes with a combination of insulin (novolin r; sliding scale and nph; 10 units twice daily).The patient reported administering an unspecified dose of insulin based on the alleged inaccurate reading then "passed out." emergency medical services (ems) were contacted for assistance.The patient stated that the paramedics treated him at around 10:30-11:00 pm with 2 glasses of orange juice and a little peanut butter.The patient claimed his blood glucose was measured on the ems device but was unable to recall the result obtained.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.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 received medical intervention for an acute low blood glucose excursion after taking insulin based on an alleged inaccurate result obtained with the subject meter.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: 10435926
• MDR Text Key: 203844123
• Report Number: 2939301-2020-02688
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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: 4626717
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention