MAUDE Adverse Event Report: APEX BIOTECHNOLOGY CORP. GLUCOCOARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

Model Number	571100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter was returned to arkray (importer) and evaluated and complaint was confirmed.Battery compartment was corroded due to battery leak.Readings are mmol/l not in mg/dl.Meter was working fine and suddenly turned off.After moving the batteries, meter was able to stay on.Audio function does not work properly.It cut off and sometimes doesn't work.After cleaning the battery compartment and battery prongs, meter audio started working properly.Meter readings are still displaying in mmol/l format, but the meter audio is saying mg/dl format.Meter sent to manufacturer for further evaluation.Apex (manufacturer) received and evaluated the subject meter.Investigation results indicated that: battery leakage leads to incorrect blood glucose unit.Incomplete audio and abnormal flashing on the lcd display are due to the poor batteries quality inserted into the meter.Meter reading displaying in mmol/l but the audio saying in mg/dl format is not confirmed.Meter displaying and audio is always consistent.(b)(4).
Event or Problem Description
Results are being displayed in decimals.Caller is calling in on behalf of her mother.Customer has an expression meter, owned three years.Customer inquired how to get the meter out of decimal mode.Readings from meter memory: 4.6; 6.8 and 11.1.(b)(4).Customer was instructed on the return label process.I informed the customer it may take 3-5 business days for delivery via ups.Please replace meter and send return label.

• Brand Name: GLUCOCOARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• MDR Report Key: 9789889
• Report Number: 9616936-2018-00005
• Device Sequence Number: 19379425
• Product Code: NBW
• UDI-Device Identifier: 00015482570101
• UDI-Public: (01)00015482570101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 06/22/2018
• Report Date (Section F): 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2018
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1