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

Model Number	571100
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of returned glucocard expression meter (el469029) reported are the functional test and venous blood test.Results of both test are acceptable.
Event or Problem Description
Patient's brother-in-law (b)(6) is calling regarding patient who is receiving emergency medical treatment at time of call.Brother-in-law heard noise in his bedroom, roommate went in and patient was not responsive.Caller is stating meter has given him false readings.Ambulance was called and patient's blood sugar was reading 20 with ambulance meter.Ambulance personnel gave customer orange juice and advised family members to give him something to eat.The patient was not taken to the hospital.The emergency personnel advised family members to call for a new meter.Patient was taking a blood test with his expression meter and it read 61.It was verified with caller that patient is using correct technique applying the blood.Advised caller to have patient test again with same hand, different finger so we can check for a variance.Patient is having a hard time getting blood and family members are advising him to squeeze his finger.Advised against squeezing finger to provide more blood but family member was not taking advice.Caller is now testing patient with his meter and refusing to do another test with the patient's expression meter saying it is defective and to send another one for replacement.Caller performed a test with his own meter, and it read at 95.Patient is now feeling better.Patient was unaware if any symptoms occurred before he became unresponsive; he does not remember anything but going to his room after breakfast to watch tv.The caller does not know if the patient was having symptoms as he was in his room unsupervised.Caller was able to access memory and his last reading before the incident was 107 at 3:56 pm which he stated was right before the incident.It is unknown if patient washed his hands before this reading, but caller states he usually does.Caller states he uses new lancets for every test.Replaced meter, strips and sent return label.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: GLUCOCARD EXPRESSION 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: 9760789
• Report Number: 9616936-2020-00001
• Device Sequence Number: 713443
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• 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
• Type of Report: Initial
• Report Date (Section B): 01/19/2020
• Report Date (Section F): 02/07/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/18/2020
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S1812012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2020
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 02/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 99
• Date Report Sent to FDA: 02/07/2020