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

Model Number 51850

Device Problem Calibration Error (1078)

Patient Problems Bacterial Infection (1735); Hypoglycemia (1912)

Event Date 06/18/2017

Event Type  Injury  

Event Description

It was reported that medical attention was sought on (b)(6) 2017 at 2:00 pm after the end user stated that her test strip were not responding with her prodigy diabetes meter.The end user passed out while in the swimming pool and was immediately retrieved.The paramedics were called and performed a blood glucose test with their meter and the result was 19 mg/dl.The end user was transported to the er and d50 along with sugar water was administered to assist in stabilizing her blood glucose.Upon arrival to the er she received an additional dose of d50 with sugar water.A chest x-ray, blood work and a nose swab were performed.The end user was diagnosed with (b)(6).After 3 - 5 hours in the er the end user was discharged and instructed to follow-up with her pcp.No additional details were provided in regards ot 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: 6760766
• MDR Text Key: 81619603
• Report Number: 3008789114-2017-00074
• 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: 08/02/2017,07/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• 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: 08/02/2017
• Distributor Facility Aware Date: 07/29/2017
• Event Location: Other
• Date Report to Manufacturer: 08/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HUMALOG 16 UNITS 3 TIMES A DAY; LEVEMIR 16 UNITS AT BED TIME; REGLAN 25 MG 4 TIMES A DAY
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 87