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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Model Number 021-105
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Chest Pain (1776); Headache (1880); Nausea (1970); Diaphoresis (2452)
Event Date 05/22/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, the patient contacted lifescan (lfs) usa, alleging that their onetouch ultra 2 meter returned inaccurate low results compared to a hospital meter.The complaint was classified based on the customer care agent (cca) documentation.The patient stated that the alleged inaccuracy issue occurred on the night of (b)(6) 2021 before the patient went to bed.They claimed they obtained results of ¿78 mg/dl¿, ¿68 mg/dl¿ and ¿72 mg/dl¿ on the subject device.The patient manages their diabetes with oral medication (metformin, steglatro and glimepiride).The patient ate a chocolate bar prior to going to sleep in response to the low results however at 04:13 the patient began to experience ¿sweating, nausea, headache and chest pain¿ so went to the hospital emergency room.On arrival, a blood glucose test was performed on a hospital meter and the result was reported as ¿414 mg/dl¿.The hospital then treated the patient with insulin.At the time of troubleshooting, the cca noted the unit of measure was set correctly on the subject meter.The patient did not have control solution to conduct a performance test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment for an acute high blood glucose excursion while using the product and the subject meter could not be ruled out as a cause or contributor to the event.
 
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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 Key12007614
MDR Text Key256452459
Report Number2939301-2021-02879
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00353885008372
UDI-Public00353885008372
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/16/2021
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
Device Operator Lay User/Patient
Device Model Number021-105
Device Catalogue Number021-105
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/24/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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