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

Model Number	50302
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hypoglycemia (1912); Seizures (2063)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because device was not returned to ok biotech, therefore, we were unable to perform further testing on the suspected device.Ok biotech reviewed the manufacturing record of this suspected device (meter serial number # (b)(4)), and the meter was qualified and released by the quality control department and shipped to (b)(4) on 05/26/2015.The strip lot # d160720-1 was manufactured on 07/20/2016 and expired in 07/2018.Ok biotech received no complaints from same manufacturing batch of strips.We tested the retain strips test of same batch#d160720-1 with in house meter and control solution.The control solution tests for level low were 59/61 mg/dl; for level high were 230/228 mg/dl.The request control solution ranges are: level low 30~80 mg/dl; level high 190~290 mg/dl.All results were within the acceptance range.Pass.We are unable to confirm the complaint because device was not returned and no further information from customer has been received, this matter has to be closed out with undetermined root cause.
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2017 at 10:30 am after the end users prodigy diabetes meter was not operating properly and he was unable to obtain an appropriate reading.The end user experienced a low blood glucose seizure accompanied with a reading of 62 mg/dl.The paramedics were called and upon arrival they performed a blood glucose test with their meter and the result was 42 mg/dl.The end user was given an iv and dextrose injection along with being transported to the er.Simultaneously he received another dextrose injection and iv saline.A blood glucose test was performed as well as examining his potassium levels.At the time of this call the end user was currently still in the hospital and no additional details were provided in regards to this medical event.

• 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, hsinchu 30070 ; TW 30070
• MDR Report Key: 6921374
• Report Number: 3005862821-2017-00098
• Device Sequence Number: 19184302
• Product Code: NBW
• UDI-Device Identifier: 00384840503021
• UDI-Public: 00384840503021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/08/2017

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: 07/20/2018
• Device Model Number: 50302
• Device Catalogue Number: 50302
• Device Lot Number: 52800 - D160720-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: 22 YR
• Patient Weight: 82