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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Incontinence (1928); Sweating (2444)

Event Date 06/20/2018

Event Type  Injury  

Event Description

Reporter alleged that on (b)(6) 2018 at approximately 1230, medical attention was sought due to the end-user being hypoglycemic.Reporter stated on initial contact "my wife had an extreme sugar low yesterday, yesterday morning her sugar tested using this meter and test strips at 89.I gave her, her prescribed insulin dosage at 830 in the morning and about 1030 she was not feeling well, laid down to take a nap.I went to wake her up for lunch at 1230, i couldn't wake her up, she was unconscious in cold sweat.It looked like symptoms of a sugar low to me, i retested her sugar using the same meter it read 72.I called 911 they dispatched an ambulance, the ambulance tested her sugar at 28.She was admitted to the hospital, spent the night in the hospital with ivs, they got her sugar under control and she's at home now." reporter stated that approximately 20-30 minutes were between testing the prodigy meter and the paramedics testing the end-user.Reporter stated the paramedics gave the end-user an "iv glucose solution" and transported end-user to the hospital.Reporter is unaware of what the end-user blood glucose was upon arrival at the hospital.Reporter stated that no other treatment was provided not related to raising the end-user's blood glucose.End-user had a cat scan and x-ray done, reporter stated results were normal.End-user spent approximately 22 hours at the hospital and was discharged with blood glucose of 211 mg/dl.End-user was provided discharge instruction to reduce insulin, reporter did not want to provide details of what insulin, how much to reduce or provide any more information.No other information was provided regarding this event.

• Brand Name: PRODIGY POCKET
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu, ; TW
• MDR Report Key: 7689945
• MDR Text Key: 114139317
• Report Number: 3008789114-2018-00034
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00384840503021
• UDI-Public: 00384840503021
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2018
• Distributor Facility Aware Date: 06/22/2018
• Event Location: Home
• Date Report to Manufacturer: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104