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

Model Number 51850

Device Problems Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986); Temperature Problem (3022)

Patient Problems Fatigue (1849); Ambulation Difficulties (2544)

Event Date 10/27/2017

Event Type  Injury  

Event Description

It was reported that medical attention was sought on (b)(6) 2017 at 12:30 pm after the end user received higher than normal blood glucose results from his prodigy diabetes meter.It was also discovered that the end user was not handling his test strips properly by ensuring that the vial is closed tightly after each use.The desiccants in the bottom of the vial are red which could constitute improper storage and expose the test strips to elevated humidity and temperature ranges outside the required standards.The end user experienced confusion, fatigue and couldn't walk accompanied with a high blood glucose reading of 428 mg/dl.An additional blood glucose test was performed 15 minutes later with a reading of 293 mg/dl.The end user was taken to the er and upon arrival his blood glucose reading was 128 mg/dl.Due to the fact that his blood glucose was within normal range no treatment or additional testing was necessary.After 2 hours in the er the end user was discharged with a blood glucose reading of 128 mg/dl.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: 6994267
• MDR Text Key: 90869497
• Report Number: 3008789114-2017-00117
• 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: 11/01/2017,10/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• 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: 11/01/2017
• Distributor Facility Aware Date: 10/28/2017
• Event Location: Home
• Date Report to Manufacturer: 11/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 113