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

Model Number 51850

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problems Pneumonia (2011); Sweating (2444); Lethargy (2560)

Event Date 01/30/2018

Event Type  Injury  

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 pdc on (b)(6) 2013.The strip lot # d170323-1 was manufactured on 03/23/2017 and expired in 03/23/2019.We received no complaints from same manufacturing batch of strips.We tested the retain strips of same batch (lot#d170323-1) with our in house meter and control solution.The control solution tests for level low were 70/72 mg/dl; for level high were 264/271 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 220~330 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 Description

It was reported that medical attention was sought on (b)(6) 2018 at 7:30 pm after the end user alleged that she was receiving higher than normal blood glucose results from her prodigy diabetes meter.The end user was incoherent, sweating and had a glassy look in her eyes accompanied with a blood glucose reading of 77 mg/dl.An additional blood glucose test was performed with her prodigy diabetes meter and the result was 100 mg/dl.The paramedics were called and upon arrival they performed a blood glucose test with their meter and the result was 32 mg/dl.An iv was administered to assist in stabilizing her blood glucose level and she was transported to the er.The end user could not recall what treatment was given or what her blood glucose reading was once she got to the er.An x-ray and blood work were performed and the end user was diagnosed with pneumonia.After 2 hours in the er, the end user was discharged and instructed to take a series of antibiotics.No additional details were provided in regards to this medical event.

Event Description

This is a supplemental report to initial report 3005862821-2018-00014 to submit investigation results from the manufacturer for the suspect devices.Devices were returned from prodigy diabetes care on feb.26, 2018 and an investigation results of the suspect devices were completed by ok biotech.

Manufacturer Narrative

Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.Okb tested the standby current of return meter, the result was1.2¿a.The criteria is <55¿a.Pass.Meter setting, audio and all buttons function are ok.Okb tested the suspected meter with in house control solution and returned strips (strip lot number:d170323-1 ).The control solution tests for level low were 61/62 mg/dl, for level high were 269/260 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 220~330 mg/dl.All results were within the acceptance range.Pass.We tested the retain strips from our warehouse (strip lot number:d170323-1 ) with returned meter and in house control solution.The control solution tests for level low were 67/68 mg/dl; for level high were 268/266 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 220~330 mg/dl.All results were within the acceptance range.Pass.

• 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, taiwan 30070 ; TW 30070
• MDR Report Key: 7298585
• MDR Text Key: 101116102
• Report Number: 3005862821-2018-00014
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00384841518505
• UDI-Public: 00384841518505
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2019
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: 52800 - D170323-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMARYL 4MG; LASIX 20MG; LEVAQUIN 500MG; LOSARTAN 50MG; METOLAZONE 5MG; METOPROLOL 25MG; NOVOLIN 70/30: 130U AM; NOVOLIN N 50U BEDTIME; NOVOLIN R: 40U DINNER; SIMVASTATIN 20MG; TOPAMAX 100MG
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 98