MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	5630996
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Diaphoresis (2452); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2023, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio 2 meter displayed inaccurately erratic blood glucose results.The complaint was classified based on the customer care agent (cca) documentation of the initial call.The patient alleged that the issue began on (b)(6), 2023, at 7:56 pm.The patient obtained blood glucose readings of ¿387, 68, 349, 323, 88, 95 and 72 mg/dl¿ on the subject meter, within 20 minutes of each other.The patient manages her diabetes with unspecified insulin, dosage based on the meter readings.The patient stated that she took her usual dose of insulin in response to the alleged issue.Immediately after the alleged issue occurred, the patient developed symptoms of ¿dizzy, shaking, headache, sweating and confusion¿.The patient denied receiving any treatment for the reported symptoms.During troubleshooting, the cca established that the test strips had not been open longer than the discard date, had not expired, and had been stored correctly.The reporter confirmed that the patient had used an approved sample site to obtain the blood sample and that the patient had used a correct testing method.The patient did not have control solution available to test the subject meter.A replacement meter was sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking her usual dose of insulin based on alleged inaccurate erratic results obtained with the subject meter.
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.

• Brand Name: OT VERIO 2 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: 18308717
• Report Number: 3008382007-2023-00067
• Device Sequence Number: 12300033
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131363
• 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): 12/12/2023

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: 5630996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/12/2023
• 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
• Patient Sex: Female