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

Lot Number 5618213

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Abrasion (1689); Hypoglycemia (1912); Diaphoresis (2452); Lethargy (2560); Presyncope (4410)

Event Date 03/21/2024

Event Type  Injury  

Event Description

On march 22, 2024, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was displaying error messages of ¿error 2¿ and ¿error 4¿.The complaint was classified based on the customer care agent (cca) documentation during the initial call.The patient reported that the alleged issue started on (b)(6) 2024, at 2 pm.The patient manages her diabetes with self-adjusting insulin (rnn injection 5 times per day) and did not report any changes made in response to the alleged issue.The patient stated that on the same day at 3:30 pm she developed symptoms of ¿low sugar, clammy, in faint, lethargic, face dropping¿ and ¿pain on fingers¿ because she had to poke her fingers 5 times due to the alleged issue with the subject meter.The patient immediately called 911, the fire department came and administered a glucose spray nozzle in her nose which made her feel better.The patient was then sent to the hospital with an ambulance where she also received iv fluids as treatment.During troubleshooting, the cca confirmed that the subject meter was not being used for the first time.Replacement products were sent to the patient.This complaint is being reported because the patient claims that she was unable to test her blood glucose due to the reported issue and reportedly developed signs suggestive of a serious injury adverse event and received medical treatment from a health care professional (hcp) for an acute low blood glucose excursion after the alleged meter issue began.

Manufacturer Narrative

The reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.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
• Type of Device: 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: 19009004
• MDR Text Key: 338982158
• Report Number: 3008382007-2024-00017
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5618213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female