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

Model Number	51850
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that meter was broken because of meter connector deformation.When we inserted strips into meter, meter was able to turn on, but meter was not working when we tried to apply control solution or blood to test strip.We tested the returned strips (strip lot number:d181031-2 ) with our in house meter and control solution.The control solution tests for level low were 68/62 mg/dl, for level high were 251/245 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 210~320 mg/dl.All results were within the acceptance range.Pass.So we concluded the meter was out of work because of connector deformation.The pin deformation of the connector is caused by the reverse insertion of the test strip.User operation issue.
Event or Problem Description
Caller stated that medical attention was sought on (b)(6) 2019 around 4:00pm at the end-user's home.Caller stated that her husband was not responding to her verbally, was clenching his fist and breathing shallowly.Caller stated that she tested him with his prodigy meter an received a result of 21mg/dl.Caller then called the paramedics.No food or medication was consumed while waiting for medical attention, but he did eat honey nut cheerios and take 60 units of tuojeo prior to needing medical attention.Paramedics arrived around 15 minutes later and tested the end-user with their meter and received a result of 50mg/dl.The paramedics administered glucose in an iv and transported the end-user to the hospital.Caller is unable to recall what the end-users blood glucose was when they arrived at the hospital.The end-user did not receive any treatment for his blood glucose while at the hospital other than the glucose iv.The end-user had his medication changed lantus to toujeo 3 days prior to seeking medical attention.The end-user was told to follow up with his primary dr.He was treated at (b)(6).

• Brand Name: PRODIGY AUTOCODE
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 8963884
• Report Number: 3005862821-2019-00045
• Device Sequence Number: 19462979
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D181031-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Weight: 91