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

Lot Number	5724284
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Dysphasia (2195); Syncope/Fainting (4411)
Date of Event	07/26/2024
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 july 31, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that his onetouch verio flex meter was reading inaccurately low compared to compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported feeling his glucose was high on (b)(6) 2024, at 3:22 pm.10 minutes later, the patient claimed he tested his blood glucose with the subject meter and received what he felt was an inaccurate low result of ¿151 mg/dl¿.The patient manages his diabetes with oral medication (metformin), diet and exercise.The patient denied taking any action regarding his usual diabetes management in response to the alleged issue.He reportedly called an ambulance and was taken to the emergency room and was feeling ¿dizzy, could not talk and passed out¿ in the ambulance.The patient reported that he stayed at the emergency room for 8 hours and was treated with iv fluids and advised to get a replacement meter.The patient indicated that he received a blood glucose result of ¿above 300 mg/dl¿ on the emergency room meter before receiving treatment.During the call, the patient also reported obtaining what he felt were inaccurate blood glucose readings of ¿151, 94, 96, 95, 108 and 105 mg/dl¿ with the subject meter at unspecified dates/times.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca confirmed the test strips were in good condition and the correct testing process was being followed.The cca noted the patient did not have control solution available to perform a quality control test.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after obtaining an alleged inaccurate low result with the subject meter.The subject meter could not be ruled out as a contributor to the event.

• 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: 19935266
• Report Number: 3008382007-2024-00038
• Device Sequence Number: 17375761
• 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): 08/07/2024

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: 5724284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/07/2024
• 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: Required Intervention
• Patient Sex: Unknown