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

Lot Number	5669220
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194); Diaphoresis (2452); Shaking/Tremors (2515)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the lay user/patient contacted lifescan (lfs) usa, alleging their onetouch verio flex meter was reading inaccurate erratically high.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged inaccuracy issue began on (b)(6) 2024, at 9 pm.The patient claimed that they obtained blood glucose readings with the subject device of ¿174 mg/dl¿ and ¿276 mg/dl¿ on the other hand.The patient also mentioned obtaining ¿300 mg/dl¿.The patient manages their diabetes with insulin (humulin r and humulin n, 25-50 units depending on results) and stated that they increased their insulin with an unspecified dose in response to the alleged issue.The patient claimed that at approximately 10 pm that same evening they started feeling ¿dizzy, shaking and nonstop sweating¿.The patient mentioned they felt so ¿worried¿, realized that their sugar level was not as high as the subject meter displayed, and ate something.A couple of hours later, on (b)(6) 2024, at 1 am, the patient ate something again and drank some juice.The patient continued feeling symptoms during the night, like ¿woozy and shaking¿ and called their daughter, who is a nurse, at 3:30 am.The patient indicated that they felt like they ¿could not breath¿ and was shaking and sweating so much that they needed assistance with injecting a vial of glucose.After the daughter administered the glucagon injection, some juice and food, the patient started feeling that their sugar was going up and felt better.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter, the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.The cca established that the test strips had been stored properly, were not open beyond their discard date, had not expired and the vial was not cracked or broken.The cca noted that the patient did not have control solution available at the time of the call to test the subject device.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 third party assistance because the patient was unable to treat themselves due to the hypoglycemic condition.
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 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: 20196785
• Report Number: 3008382007-2024-00042
• Device Sequence Number: 7643320
• 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): 09/11/2024

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: 5669220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/11/2024
• 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