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

Lot Number	5819252
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Dizziness (2194); Loss of consciousness (2418); Syncope/Fainting (4411)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, 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 or Problem Description
On (b)(6)2024, the patient/lay user contacted lifescan (lfs) usa alleging that their onetouch verio flex meter read inaccurately high compared to their feelings and/or normal results.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) 2024, at an unspecified time.The patient received a blood glucose reading of ¿over 300 mg/dl¿ on the subject meter.The patient manages their diabetes with insulin (humalog 3cc daily and lantus, self-adjustable dose depending on reading) and stated that they took an additional shot of humalog 3cc in response to the high reading from the subject meter.The patient indicated that another reading was obtained after, however the reading remained the same.That same day, at an unspecified time after the increase of medication, the patient started developing symptoms of ¿dry eyes, dizziness, unconscious and fainted¿.The patient¿s daughter and wife called the ambulance and a reading of ¿21 mg/dl¿ was obtained on an er meter.The patient claimed they were treated by a health care professional (hcp) with vitamin bags, food and liquids that same day.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure.The cca confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The patient did not have control solution available to test the subject meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on high readings from the subject meter, and reportedly received medical treatment.

• Brand Name: OT VERIO FLEX METER
• Common Device Name: 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: 20529152
• Report Number: 3008382007-2024-00050
• Device Sequence Number: 13022763
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 5819252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown