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

Lot Number 4644651

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Myalgia (2238); Anxiety (2328); Shaking/Tremors (2515)

Event Date 12/21/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that his onetouch ultra plus reflect meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on (b)(6) 2020 at around 5:00 pm.The patient claimed obtaining blood glucose readings of ¿186 and 199 mg/dl¿ with the subject meter, performed within 20 minutes of each other.The patient manages his diabetes with a combination of insulin (apidra before meals on a self-adjusting dose) and oral medication (xigduo 1000 mg).In response to the alleged inaccurate results, the patient claimed he took 4 units of apidra and drank water at approximately 5:00 pm.The patient claimed that around 10:30 pm, he developed symptoms of ¿trembling, muscle pain, nervous and restless;¿ symptoms he associated with hypoglycemia.At the onset of symptoms, the patient claimed he tested his blood glucose with the subject meter and obtained a result of ¿57 mg/dl.¿ the patient claimed he drank water and ate bread as self-treatment for the symptoms.No other device was used for testing.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and that the same approved sample site was used for testing.The cca noted that the patient did not have control solution available to test the subject meter.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 alleged inaccurate results obtained with the subject meter.The subject meter could not be ruled out as a contributor to the event.

• Brand Name: OT ULTRA PLUS REFLECT METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11108456
• MDR Text Key: 224889997
• Report Number: 2939301-2021-02800
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2020

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
• Device Operator: Lay User/Patient
• Device Lot Number: 4644651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening