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	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The caller is unable to send the meter back, because it is in (b)(6).Arkray explained the importance of having it returned, but the cusomter stated the shipping of the meter would cost more than the meter itself so it is not cost effective to have it shipped from india so it can be returned.(b)(4) (manufacturer) did not receive the return of subject meter.
Event or Problem Description
Caller's parents have been using this meter for three years and it has been working fine.Recently, the meter has started giving readings in "mmol/l" not "mg/dl".There is no way to change this back.The caller is unable to send the meter back, because it is in (b)(6).I explained the importance of having it returned, but the customer stated the shipping of the meter would cost more than the meter itself so it is not cost effective to have it shipped from (b)(6) so it can be returned.Customer also requested control solution.Please replace meter, send control solution, 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: 9789916
• Report Number: 9616936-2018-00007
• Device Sequence Number: 2185257
• 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
• Type of Report: Initial
• Report Date (Section B): 07/30/2018
• Report Date (Section F): 08/06/2018

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2018
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• 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