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U.S. Department of Health and Human Services

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

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LIFESCAN EUROPE GMBH OT ULTRA PLUS REFLECT METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
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.
 
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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 Key11108456
MDR Text Key224889997
Report Number2939301-2021-02800
Device Sequence Number1
Product Code NBW
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
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 Number4644651
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/22/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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