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

Lot Number	5770359
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Headache (1880); Dysphasia (2195); Lethargy (2560); Syncope/Fainting (4411); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 22, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio flex meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began around (b)(6) 2024.The patient claimed obtaining blood glucose readings of ¿108, 46 and 266 mg/dl¿ with the subject meter, performed within 20 minutes of each other.The patient manages her diabetes with a combination of diabetes medications (lantus insulin, 60 units; regular insulin, 50 units; ozempic, once weekly injection).It was not reported if the patient made any changes to her usual diabetes management regimen due to the alleged issue.The patient reported that on (b)(6) 2024, at 8:00 pm, she started having symptoms of ¿very sleepy, bad headache, lethargic, stop talking and pass out¿ and her neighbour called emergency medical services (ems) for assistance.The patient reported that at 8:30 pm, paramedics treated her with 2 bags of iv glucose and she ate a peanut butter sandwich and drank a coke.The patient claimed she received a blood glucose result of ¿261 mg/dl¿ on the ems meter at 9:30 pm.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the same approved sample site was used for testing and that the correct testing process was being followed.The cca confirmed the test strip vial was intact, and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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.
Additional Manufacturer Narrative
The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO FLEX METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness
• Manufacturer Contact: simon palmer ; beechwood park north; inverness ; 1463383679
• MDR Report Key: 20082126
• Report Number: 3008382007-2024-00041
• Device Sequence Number: 20786015
• 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,Followup
• Report Date (Section B): 08/19/2025

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: 5770359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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