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

Model Number	51850
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
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)), serial number was incorrect number and we can't find the manufacturing record for the meter.The strip lot # d170123-1 was manufactured on 01/23/2017 and expired in 01/2019.Ok biotech received no complaints from same manufacturing batch of strips.We tested the remain strips of #d170123-1 with our in house meter and control solution, the control solution tests for level low were 51/46 mg/dl; for level high were 232/238 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.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 6:00 pm after the end user received higher than normal blood glucose readings from his prodigy diabetes meter.The end user performed a blood glucose test with a result of 336 mg/dl.He did not experience any significant symptoms but out of concern he was taken to the er as a precaution.Upon arrival to the er his blood glucose was 241 mg/dl.The end user stated that no treatment was administered to stabilize his blood glucose level.Blood and urine test were performed and the results were normal.After 4 hours in the er, the end user was discharged with a blood glucose reading of 276 mg/dl and he was instructed to follow-up with his pcp.No additional details were provided in regards to this medical event.
Additional Manufacturer Narrative
Okb received the suspected meter from pdc, the serial number is # (b)(4), and the serial number in the initial report #3005862821-2017-00097 was incorrect.Okb investigated and calculated that the returned meter operated within specifications.1.We testsed the standby current of returned meter, the result was 0.7a.The criteria is <55a.Pass.2.Meter setting, audio and all buttons function are ok.3.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 59/59 mg/dl, for level high are 248/237 mg/dl.The request control solution ranges are: level low30~80 mg/dl; level high 190~290 mg/dl.All results were within the acceptance range.Pass.4.Because patient did not return his strips, so we tested the retain strips from our warehouse (same as patient's strip, strip lot number:d170123-1).The control solution tests for level low were 54/57 mg/dl; for level high were 249/257 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 or Problem Description
This is a supplemental report to initial report 3005862821-2017-00097 to submit investigation results from the manufacturer for the suspect devices.Devices were returned from prodigy diabetes care on oct.12,2017 and an investigation results of the suspect devices were completed by ok biotech.

• 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: 6921446
• Report Number: 3005862821-2017-00097
• Device Sequence Number: 16449961
• Product Code: NBW
• UDI-Device Identifier: 00384841753005
• UDI-Public: 00384841753005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: 01/23/2019
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: 52800-D170123-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91