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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONETOUCH ULTRA STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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ONETOUCH ULTRA STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Type  Death  
Event Description
Patient is deceased - the reporter did not specify if the patient was still using this product at time of death.
 
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Brand Name
ONETOUCH ULTRA STRIPS
Type of Device
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
MDR Report Key13141735
MDR Text Key283146463
Report NumberMW5106398
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient SexFemale
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