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

Catalog Number 477540

Device Problem Low Readings (2460)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/26/2020

Event Type  Injury  

Event Description

Caller stated that medical attention was sought on (b)(6) 2020 due to her equate test strips giving a low result.The caller stated that she gave her son insulin based off the result she received when she tested his blood glucose with the equate test strips.She stated that this caused her to have to take her son to the hospital.We have attempted to contact the caller to obtain more information and left multiple messages and the caller has not called back to provide us with more information.We do not have any information on the end-user.No additional information was provided.

• Brand Name: EQUATE BLOOD GLUCOSE STRIPS
• Type of Device: BLOOD GLUCOSE TEST STRIP
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 10267632
• MDR Text Key: 199900557
• Report Number: 3008789114-2020-00032
• 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: 06/17/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2021
• Device Catalogue Number: 477540
• Device Lot Number: U19100412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/27/2020
• Event Location: Home
• Date Report to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization