MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO TEST STRIP; GLUCOSE MONITORING SYS/KIT

Lot Number 5628409

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Dysphasia (2195)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.

Event Description

On (b)(6), 2023, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio test strips are sticking together.The complaint was classified based on the customer care agent (cca) documentation of the initial call.The patient reported that the alleged issue started on (b)(6), 2023, when she got a meter kit and a box of test strips.The patient indicated that at first, she disregarded the fact that the test strips were stuck together but after a couple of days it started affecting how she would normally test.The patient manages her diabetes with novolog and lantus insulin based on sliding scale (novalog (depending on her blood sugar) 3 units in the morning, 3 units at lunch, 5 to 6 units depending on her dinner, lantus 5 units at 9 pm depending on low or high blood sugar).The patient stated that she continued taking her usual medication in response to the alleged issue.On (b)(6), 2023, at 2:57 pm the patient started feeling ¿funky¿ and ¿it was hard for her to talk¿.The patient claimed that due to the issue, she feels insecure as she is not able to test her blood sugar and the patient mentioned that she fears dying in her sleep.The patient denied that she received any medical treatment due to the alleged issue.The patient indicated during the call with lfs that she would just wait and would not take medication due to how she was feeling.During troubleshooting, the cca established that the test strips were not being used for the first time and the cca confirmed that the test strips were sticking due to static.However, the issue remained unresolved.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged strip issue began.

• Brand Name: OT VERIO TEST STRIP
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 18037082
• MDR Text Key: 326905669
• Report Number: 3008382007-2023-00057
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5628409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening