MAUDE Adverse Event Report: OK BIOTECH CO., LTD. EQUATE BLOOD GLUCOSE STRIPS; BLOOD GLUCOSE TEST STRIPS

Catalog Number 477540

Device Problem Low Readings (2460)

Patient Problem No Information (3190)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

No non-conformity was found after okb reviewed all manufacturing and qc records of strips (lot#: u19100412).Strips were manufactured on 10/04/2019 and will expire in 10/2021.Because the suspected strips were not returned to okb, the retained strips (lot#: u19100412) from okb's warehouse were used to re-test with onetouch meter (code: 49) and control solution (level low: batch# 8ah1a95, exp.By dec., 2020; level high: batch# 8ah3a15, exp.By dec., 2020).Testing results (level low: 46/43; level high: 259/256) met the acceptance criteria (level low: 30~80; level high: 230~340), and desiccants of strip vial are functional.The root cause of the complaint is unable to be verified without the suspected strips and more user's information.Therefore, the matter has to be closed out if no further action or information from the user.

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 STRIPS
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no.91, sec. 2; gongdao 5th rd.; hsinchu, 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no.91, sec. 2; gongdao 5th rd.; hsinchu, 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no.91, sec. 2; gongdao 5th rd.; hsinchu, 30070 ; TW 30070
• MDR Report Key: 10238045
• MDR Text Key: 204922289
• Report Number: 3005862821-2020-00037
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 07/07/2020
• 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
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization