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

Lot Number 4802438

Device Problems Failure to Obtain Sample (2533); Material Twisted/Bent (2981)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Similar complaints for these issues 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 may 06, 2022, the lay user/patient contacted lifescan (lfs) (b)(4), alleging that their onetouch verio test strips were bent and only partially filled after a sample was applied.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that alleged issues began (b)(6) 2022.The patient stated that they are sometimes unable to obtain a blood glucose reading due to the alleged issues.The patient claimed they developed symptom of ¿shaking¿ between 4:00 pm and 5:00 pm before dinner almost every day since (b)(6) 2022; symptom they associated with a low blood glucose.The patient claimed they attempted to test their blood glucose in response to the symptom however quickly self-treated with food and drink.The patient informed the cca that they manage their diabetes with a fixed dose of insulin (3 doses of rapid-acting insulin; 1 dose of lantus) and skipped insulin as a result of the alleged issue.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and the correct test strips were being used for testing.The patient was unwilling to walk through resolving the issue.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged issues began.The subject test strips could not be ruled out as a contributor to the event.

• Brand Name: OT VERIO TEST STRIP
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; 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: 14381822
• MDR Text Key: 292731251
• Report Number: 3008382007-2022-04308
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4802438
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2022
• 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