MAUDE Adverse Event Report: TYSON BIO. MEMBER'S MARK; BLOOD GLUCOSE METER

Catalog Number 707001

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Loss of consciousness (2418)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user of the member's mark easytouch glucose meter called on (b)(6) 2022 to report an adverse event while using the member's mark easytouch glucose meter in (b)(6) 2022.Exact date is unknown, user cannot remember.User tested at 159 mg/dl in the late afternoon after snacking on cheese and crackers.She submitted that information into her medtronic insulin pump which automatically doses her with the 'proper amount of insulin' (user takes humalog).After the insulin dose she settled back into her tv show and her daughter found her slumped over - passed out on the couch around 6:30-7:00 when she arrives home from work.The daughter called the ambulance which tested her at 22mg/dl and then took her to the hospital via ambulance.She then only stayed at the hospital for a few hours until her glucose remained stable.The user now has a dexcom glucose meter which she relies on and does not use the easytouch glucose meter any longer since the incident.The user stores her test strips in the living with her meter on the couch.This is not the first member's mark easytouch glucose meter the user has had, the user has used member's mark easytouch glucose meter many years, this most recently purchased glucose meter was purchased in (b)(6) 2022 along with the easytouch glucose test strips.User has agreed to returned the member's mark easytouch glucose meter and test strips to mhc medical products for quality testing.

Event Description

End user of the member's mark easytouch glucose meter called on (b)(6) 2022 to report an adverse event while using the member's mark easytouch glucose meter in may 2022.Exact date is unknown, user cannot remember.User tested at 159 mg/dl in the late afternoon after snacking on cheese and crackers.She submitted that information into her medtronic insulin pump which automatically doses her with the 'proper amount of insulin' (user takes humalog).After the insulin dose she settled back into her tv show and her daughter found her slumped over - passed out on the couch around 6:30-7:00 when she arrives home from work.The daughter called the ambulance which tested her at 22mg/dl and then took her to the hospital via ambulance.She then only stayed at the hospital for a few hours until her glucose remained stable.The user now has a dexcom glucose meter which she relies on and does not use the easytouch glucose meter any longer since the incident.The user stores her test strips in the living with her meter on the couch.This is not the first member's mark easytouch glucose meter the user has had, the user has used member's mark easytouch glucose meter many years, this most recently purchased glucose meter was purchased on (b)(6) 2022 along with the easytouch glucose test strips.User has agreed to returned the member's mark easytouch glucose meter and test strips to mhc medical products for quality testing.

Manufacturer Narrative

The performance of the retention test strips and glucose meter confirmed to be in good condition after investigation.The manufacturer concluded that the test strips being used by the end user could have had a malfunction based on the complaint reported however, due to the testing of the retention strips and user's glucose meter, the measurements fell into the accepted ranges and shows the system is working properly.In conclusion, "the hospitalization of the end user is a single case and has no direct relation to the easy touch system".

• Brand Name: MEMBER'S MARK
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): TYSON BIO.; lot 95-b, xishen road; wuxi new district; wuxi, jiangsu 21402 8; CH 214028
• Manufacturer (Section G): TYSON BIO.; 5f., no. 16, 18, 20, 22, kedon; zhunan, township; miaoli, jiangsu 35053 ; TW 35053
• Manufacturer Contact: biing-ru ; 5f., no. 16, 18, 20, 22, kedon; zhunan township; miaoli, jiangsu 35053
• MDR Report Key: 14648743
• MDR Text Key: 293683209
• Report Number: 3005798905-2022-03064
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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 Catalogue Number: 707001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization