MAUDE Adverse Event Report: OK BIOTECH CO., LTD. PRODIGY AUTOCODE; BLOOD GLUCOSE MONITORING DEVICE

Model Number 51850

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problems Chest Pain (1776); Pneumonia (2011)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.Okb tested the standby current of returned meter, the result was 1.2 a.The criteria is <55 a.Pass.Meter setting, audio and all buttons function are ok.We tested the suspected meter with in house control solution and in house strips (strip lot number:d160526-1).The control solution tests for level low were 60/60 mg/dl, for level high were 250/248 mg/dl.The request control solution ranges are: level low 30~80 mg/dl; level high 190~300 mg/dl.All results were within the acceptance range.Pass.Because patient did not return her strips, so we tested the retain strips of same batch from our warehouse (same as patient 's strip, lot number:d170207-1) with returned meter and in house control solution.The control solution tests for level low were 60/58 mg/dl; for level high were 234/233 mg/dl.The request control solution ranges are: level low 30~80 mg/dl; level high 200~310 mg/dl.All results were within the acceptance range.Pass.

Event Description

It was reported that medical attention was sought on (b)(6) 2018 at 5:00 pm after the end user alleged she received higher than normal blood glucose results from her prodigy diabetes meter.The end user was experiencing symptoms associated with pneumonia - coughing, wheezing, heavy breathing and chest pains.The paramedics were called and while waiting on their arrival a blood glucose test was performed with her prodigy diabetes meter and the result was 487 mg/dl.Subsequently upon their arrival the paramedics performed a blood glucose test with their meter and the result was 130 mg/dl.No treatment was administered and the end user was transported to the er.Once she arrived to the er an additional blood glucose test was performed with the hospitals meter and the result was 130 mg/dl and no further treatment was warranted.A chest x-ray was performed with close observation.After 5 hours in the er the end user was discharged and stated she has an upcoming appointment with her pcp and a cardiologist.No additional details were provided in regards to this medical event.

• Brand Name: PRODIGY AUTOCODE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec.2; gongdao 5th road; hsinchu, taiwan 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no. 91, sec.2; gongdao 5th road; hsinchu, taiwan 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no. 91, sec.2; gongdao 5th road; hsinchu, taiwan 30070 ; TW 30070
• MDR Report Key: 7340610
• MDR Text Key: 102442425
• Report Number: 3005862821-2018-00020
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00384841518505
• UDI-Public: 00384841518505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2019
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D170207-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ABUDURALVITIMIN C; ALBUTEROL; BD INSULIN PEN NEEDLE - UF LANTUS; BENEFIBER; CALACLEAR LOTION; CHOLECALCIFEROL; CLOPIDOGREL; CLOTRIMAZOLE CREAM; CRANBERRY EXTRACT; DILTIAZEM; DOCUSATE SODIUM; ESCITALOPRAM OXALATE; EZETIMIBE; FLONASE; FUROSEMIDE; GABAPENTIN; HYDROCODONE; INSULIN ASPART- NOVOLOG; LAMOTRIGINE; LANTUS SOLOSTAR; LORAZEPAM; METOPROLOL SUCCINATE; MULTIVITAMIN; NITROSTAT; PANTOPRAZOLE; POTASSIUM CHLORIDE; PRO AIRFASA; RANEXA; SILVADENE; TRAMADOL; VICKS VAPORUB OINTMENT; VITIMIN C; WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 120