MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD UNISTRIP1; BLOOD GLUCOSE TEST STRIP

Model Number 477540

Device Problems High Readings (2459); Device Operational Issue (2914); Output Problem (3005)

Patient Problem No Information (3190)

Event Date 02/07/2017

Event Type  Injury  

Event Description

It was reported that medical attention was sought on (b)(6) 2017.The end user stated that her test strips were reading 20 points above the actual test results.Several attempts were made to contact the end user so that additional information could be obtained in relations to this medical event.The end user failed to return any calls so therefore no additional information is available.

• Brand Name: UNISTRIP1
• Type of Device: BLOOD GLUCOSE TEST STRIP
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu, 300 ; TW 300
• MDR Report Key: 6654594
• MDR Text Key: 78016111
• Report Number: 3010622184-2017-00001
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2017,04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 477540
• Device Catalogue Number: 477540
• Device Lot Number: U16110812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2017
• Distributor Facility Aware Date: 04/18/2017
• Date Report to Manufacturer: 06/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 79