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

Model Number 51850

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905)

Event Date 02/18/2018

Event Type  Injury  

Event Description

It was reported that medical attention was sought on (b)(6) 2018 at 7:00am after the end user alleged that she received higher than normal blood glucose results from her prodigy diabetes meter.Subsequently it was also discovered that she was using expired test strips that were open past 90 days.The end user was educated on the proper use of her test strips once the vial has been opened.The end user performed a blood glucose test with her prodigy diabetes meter and the result was 531 mg/dl.She did not experience any significant symptoms and out of concern for the high reading she was taken to the er.Upon arrival to the er an additional blood glucose test was taken with the hospitals meter and the reading was 150 mg/dl.She received saline to assist in stabilizing her blood glucose level.An x-ray was performed which revealed that she had a cracked rib.After 4 hours in the er the end user was discharged and instructed to follow-up with her pcp.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: 7288533
• MDR Text Key: 100667587
• Report Number: 3008789114-2018-00017
• 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: 02/22/2018,02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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: 02/22/2018
• Distributor Facility Aware Date: 02/20/2018
• Event Location: Home
• Date Report to Manufacturer: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 3 L OXYGEN PER MIN; ALPRAZOLAM .5MG DAILY; AMOXICILLIN 500MG; CALCIUM; DIGOXIN .125 MG DAILY; FIORICET; JANUVIA 50 MG; LASIX 40MG; LOMOTIL 2.5MG AS NEEDED; METOPROLOL 75MG 2X A DAY; MULTIVITAMINS; NITROGLYCERIN .2MG 12 HOURS DAILY; SIMVASTATIN 20MG DAILY; TRAMADOL HCL 550MG; WARFARIN 5MG DAILY
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 68