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

Model Number	021-924
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultramini meter was reading inaccurately high compared to his feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged inaccuracy issue began at unknown time before (b)(6) 2021.The patient claimed obtaining a blood glucose reading of ¿200 mg/dl¿ with the subject device which he felt was inaccurately high compared to his feelings and/or normal readings.The patient manages his diabetes with self-adjusted insulin ¿novolog and lantus¿ (dose unknown).The patient reported that he took an unspecified shot of insulin in response to the alleged result.The patient reported that at 1:30pm on (b)(6) 2021, after obtaining the alleged inaccurately high blood glucose reading, he developed symptoms of ¿lightheaded, dizzy and about to pass out¿.The patient stated that he self-treated with food and drink ¿orange juice¿.He retested his blood and obtained a blood glucose result of 60mg/dl on another, unknown device.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device at the time of testing.The cca also noted that the patient did not have control solution available at the time of the call to test the subject system.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention, administered by a third party after reportedly developing symptoms suggestive of a serious injury adverse event for an acute low blood glucose excursion after administering medication based on the alleged inaccurately high blood glucose readings obtained on the subject device.

• Brand Name: OT ULTRA MINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11713067
• Report Number: 2939301-2021-02853
• Device Sequence Number: 17185648
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 021-924
• Device Catalogue Number: 021-924
• Device Lot Number: 4690180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening