MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY AUTO CODE; BLOOD GLUCOSE MONITORING DEVICE

Model Number 51850

Device Problem Invalid Sensing (2293)

Patient Problem Hypoglycemia (1912)

Event Date 01/30/2018

Event Type  Injury  

Event Description

It was reported that medical attention was sought on (b)(6) 2018 at 7:30 pm after the end user alleged that she was receiving higher than normal blood glucose results from her prodigy diabetes meter.The end user was incoherent, sweating and had a glassy look in her eyes accompanied with a blood glucose reading of 77 mg/dl.An additional blood glucose test was performed with her prodigy diabetes meter and the result was 100 mg/dl.The paramedics were called and upon arrival they performed a blood glucose test with their meter and the result was 32 mg/dl.An iv was administered to assist in stabilizing her blood glucose level and she was transported to the er.The end user could not recall what treatment was given or what her blood glucose reading was once she got to the er.An x-ray and blood work were performed and the end user was diagnosed with pneumonia.After 2 hours in the er the end user was discharged and instructed to take a series of antibiotics.No additional details were provided in regards to this medical event.

• 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, 300 ; TW 300
• MDR Report Key: 7237122
• MDR Text Key: 98867851
• Report Number: 3008789114-2018-00010
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00384841518505
• UDI-Public: 00384841518505
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018,01/31/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2018
• Distributor Facility Aware Date: 01/31/2018
• Event Location: Home
• Date Report to Manufacturer: 02/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMARYL 4MG; LASIX 20MG; LEVAQUIN 500MG; LOSARTAN 50MG; METOLAZONE 5MG; METOPROLOL 25MG; NOVOLIN 70/30: 130U AM; NOVOLIN N 50U BEDTIME; NOVOLIN R: 40U DINNER; SIMVASTATIN 20MG; TOPAMAX 100MG
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 98