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

Model Number	51850
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	06/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.We tested the standby current of returned merer, the result was 0.9ua.The criteria is <55ua.Pass.Meter setting, audio and all buttons function are ok.We tested the suspected meter with in house control solution and returned strips (strip lot number: d170828-1, only 5 pcs).The control solution tests for level low were 63/63 mg/dl, for level high were 249/251 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 200~310 mg/dl.All results were within the acceptable range.Pass.However we found the desiccant inside the strip bottle had color changed.We tested the retain strips from our warehouse (strip lot number: d170828-1).The control solution tests for level low were 64/65 mg/dl; for level high were 250/259 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 200~310 mg/dl.All results were within the acceptance range.Pass.Because the desiccant color changed from patient's strips, indicate the strips might get moisture.Patient used those strips to test blood might caused or contributed to higher readings.User storage or operation issue.
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019 around 8:30pm.The caller stated that the end-user received a reading of 66mg/dl.End-user then took her insulin based off the result she received which led to the end-user being found unresponsive.Paramedics were called around 10 minutes after testing with her prodigy meter.Paramedics arrived within 10-15minutes and tested her blood glucose with their meter and received a result of 34mg/dl.There was about 20 minutes between testing with the prodigy meter and the paramedics meter.There was no food drink or medications taken while waiting for the paramedics.The end-user was given 2 glucose iv solutions and was not transported to the hospital.The end-user takes the following insulin lantus 25 units at noon, novolog 2-10 units when she eats, novolog 20 units when result is over 400mg/dl.No additional details were provided.

• 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: 8863536
• Report Number: 3005862821-2019-00033
• Device Sequence Number: 10840698
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/11/2019

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: 08/28/2019
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D170828-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/06/2019
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 64