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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY AUTO CODE; BLOOD GLUCOSE MONITORING DEVICE
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OK BIOTECH COMPANY LTD PRODIGY AUTO CODE; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Model Number 51850
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Hypoglycemia (1912)
Event Date 11/25/2018
Event Type  Injury  
Event Description
It was reported that medical attention was sought on (b)(6) 2018 between 3:00-3:30 pm after the end-user received 3 results of hi from his prodigy diabetes meter.The end-user stated that due to getting results of hi, he took 8 units of humalog which caused him to pass out.Ems was called and arrived within 5 minutes.Ems started an iv and transported the end-user to the er.End-user does not recall what his blood sugar was when he arrived.End-user stated he was given iv fluids but cannot recall what he was given.He was also given medicine to lower his blood pressure due to it being too high.End-user was hospitalized for 2 days.His blood sugar was 177mg/dl upon discharge and he was told to follow up with his primary dr.End-user was treated at (b)(6) hospital located at (b)(6).
 
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Brand Name
PRODIGY AUTO CODE
Type of Device
BLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
OK BIOTECH COMPANY LTD
no. 91, sec 2
gongdao 5th rd
hsinchu city 30070, tw,
TW 
MDR Report Key8205271
MDR Text Key131702500
Report Number3008789114-2018-00044
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00384840518858
UDI-Public00384840518858
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number51850
Device Catalogue Number51850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2018
Distributor Facility Aware Date11/30/2018
Event Location Home
Date Report to Manufacturer12/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age74 YR
Patient Weight79
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