MAUDE Adverse Event Report: APEX BIOTECHNOLOGY CORP. GLUCOCARD 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	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter was returned for evaluation to (b)(4) (importer and complaint handler).Meter was returned and evaluated and performed to specification.No failures detected.Apex (manufacturer) performed evaluation and confirmed the problem with returned meter (b)(4).Corrective actions are initiated to improve the problem.(b)(4).
Event or Problem Description
(b)(6) pharmacist calling on behalf of customer.Customer gave permission to speak with (b)(6).(b)(4).Caller has owned meter for two years.Customer went to the pharmacy because her meter giving results in mmol/l.(b)(6) wanted to know how to go about changing it back to mg/dl.I explained to (b)(6) that there is no way to go about doing so and we would bave to replace the meter.Please replace meter and send return label.

• Brand Name: GLUCOCARD 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: 9789827
• Report Number: 9616936-2018-00002
• Device Sequence Number: 2185255
• 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: Pharmacist
• 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: 04/30/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2018
• Device Age: 6 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