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

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

Patient Problems Fatigue (1849); Chills (2191); Malaise (2359); Coma (2417); Sweating (2444); Alteration In Body Temperature (2682)

Event Date 01/23/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter read inaccurately high compared to her feelings and/or normal readings and compared to another meter (emergency medical services device).The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the cca during a follow-up call with the patient on july 17, 2020.The patient reported that on (b)(6) 2020 at around 3:00 am she woke up to find a team of emergency medical technician's (emts) at her bedside administering intravenous (iv) glucose.The patient claimed that once they had stabilized her condition, they informed her that she had gone into a "diabetic coma due to dangerously low blood sugar." prior to emts arriving, the patient's husband reportedly woke up to find the patient "hot and sweaty." he proceeded to check the patient's continuous glucose monitoring (cgm) device which read "285" and gave the patient 12 units of insulin in response.According to the information provided by the patient, her glucose only came down slightly and her husband "could not arouse her." the emergency medical services (ems) were contacted for assistance and when they arrived, the patient's blood glucose measured "very high" with the subject meter (exact result not provided) and "23 mg/dl" on the ems device.The patient reported that after she was treated with iv glucose, she was taken to hospital for further treatment and monitoring.She remained in hospital for several hours.The patient has type 1 diabetes and manages her diabetes with a combination of humalog and levemir insulin.According to the information provided by the patient, her glycemic control had been acutely worse after a recent miscarriage and for several days prior to the overnight hypogylycemic episode had been battling persistently high blood glucose.The patient stated that for several days prior to the overnight hypoglycemic episode, she had been obtaining inaccurate high readings in the "300s and 400s mg/dl range" with the subject meter (exact results not provided).In response to the elevated readings, the patient reported that she had been injecting larger doses of insulin than usual to lower her blood glucose and had been experiencing symptoms of "feeling off, inexplicably fatigued and unwell with mild chills." the patient reported that she relies on the subject meter to test her blood glucose and to calibrate her cgm device.According to the information provided by the patient, her doctor stated the overnight hypoglycemic episode was likely attributed to the alleged meter inaccuracy which led to incorrect calibration of her cgm device.Troubleshooting was unable to be performed.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event requiring medical intervention after taking insulin based on alleged inaccurate high readings obtained with the subject meter and after being administered insulin based on a cgm device calibrated with alleged inaccurate high readings obtained on the subject meter.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10338012
• MDR Text Key: 200790620
• Report Number: 2939301-2020-02676
• Device Sequence Number: 1
• Product Code: NBW
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2020
• 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