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 Codes	Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Date of Event	07/01/2019
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 meter, the result was 0.9¿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 returned strips (strip lot number: d171117-2, only (b)(4) pcs).The control solution tests for level low were 84/87 mg/dl, for level high were 289/279 mg/dl.The request control solution ranges are: level low 40~90 mg/dl; level high 220~330 mg/dl.All results were within the acceptance 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: d171117-2).The control solution tests for level low were 65/70 mg/dl; for level high were 261/252 mg/dl.The request control solution ranges are: level low 40~90 mg/dl; level high 220~330 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 11:00am.End-user stated that he took a blood glucose test and received a result of 293mg/dl, a normal result for that time of day is 125mg/dl.He then stated that he started to feel shaky and confused.End-user stated he went to the hospital on his own.There was no food drink or medication taken prior to going to the hospital.He does not recall what is blood glucose was when he arrived.He did not receive treatment for his blood glucose levels.Doctors in the emergency room ran a cat scan and blood work and everything came back normal.End-user stated he was at the hospital for 5 hours and was not admitted.The end-users sliding scale is as follows: humalog: (sliding scale): 100-199mg/dl 7 1/2 units 200-299mg/dl 15 units 300-399mg/dl 22 1/2 units 400-499mg/dl 30 units.End-user does not recall what his blood glucose was when he was discharged from (b)(6) hospital located at (b)(6).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: 8863539
• Report Number: 3005862821-2019-00034
• Device Sequence Number: 11469186
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 11/17/2019
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D171117-2
• 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: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 92