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 Syncope (1610); Dizziness (2194)

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter was reading inaccurately high 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 by the medical surveillance specialist after reviewing the call recording.The patient reported that the alleged meter inaccuracy occurred at 7:00 am on an unspecified date when he obtained an alleged inaccurate high blood glucose reading of "185 mg/dl" with the subject meter.The patient manages his diabetes insulin (self-adjuster).In response to the elevated result, the patient claimed he took 10 units of novolog insulin then at around 8:30 am, he felt "woozy and almost passed out." during the call, the patient claimed his blood glucose tested "60 mg/dl" at the onset of symptoms on an unspecified device and that he had to call his spouse for assistance for the provision of orange juice as treatment for the symptoms.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 developed signs/symptoms suggestive of a serious injury adverse event after taking insulin based on an alleged inaccurate high result 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: 10470286
• MDR Text Key: 204934177
• Report Number: 2939301-2020-02694
• 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: 08/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 4599940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention