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

Model Number 51850

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Fainting (1847); Burning Sensation (2146)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

Suspected device returned and evaluated by ok biotech and calculated that the meter operated within specifications.We tested the standby current of returned meter, the results was 1.0ua.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 in house strips test.(strip lot number:d160526-1).The control solution tests for level low were 56/55 mg/dl, for level high were 261/244 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 tested the returned strips (strip lot number were unknown because the label was rubbed off by patient).The control solution tests for level low were 51/54 mg/dl, for level high were 254/241 mg/dl.All results were within the acceptance range.Pass.

Event Description

It was reported that medical attention was sought on (b)(6) 2017 at 9:00 am after the end user received a low blood glucose reading from his prodigy diabetes meter.The end user experienced burning in his shoulder, back, stomach and passed out.The paramedics were called and performed a blood glucose test with their meter with a result of 168 mg/dl they also performed a test with his prodigy meter and the result was 118 mg/dl.No treatment was administered by the paramedics.The end user was transported to the er by his daughter due to the fact that she was not totally satisfied with his condition.Upon arrival to the er his blood glucose reading was 125 mg/dl.An ekg and other lab work were performed and nothing abnormal was affirmed.After 4 hours at the er the end user was discharged.Initially before the medical event his insulin was changed from humalog 5 units 3 times a day to novolog 3 units 3 times a day.No further details were provided in relations to this medical event.

• Brand Name: PRODIGY AUTOCODE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2,; gongdao 5th road; hsinchu, 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no. 91, sec. 2,; gongdao 5th road; hsinchu, 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no. 91, sec. 2,; gongdao 5th road; hsinchu, 30070 ; TW 30070
• MDR Report Key: 6621206
• MDR Text Key: 76943127
• Report Number: 3005862821-2017-00048
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K073118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL 100 MG ONCE A DAY; AMLODIPINE 2.5 MG HALF A TABLET DAILY; ASPIRIN 81 MG 1 TABLET DAILY; LANTUS 5 UNITS ONCE A DAY AT NIGHT TIME; NOVOLOG 3 UNITS 3 TIMES A DAY
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 115