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

Model Number 023-271

Device Problem Device Handling Problem (3265)

Patient Problems Headache (1880); Hyperglycemia (1905); Dry Mouth (4485)

Event Date 09/04/2022

Event Type  Injury  

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.

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio flex meter was reading inaccurately low compared to another meter (humana).The complaint was classified based on a review of the call recording and on additional information obtained by the customer care agent (cca) during a follow-up call with the patient.The patient reported that on (b)(6) 2022, they obtained blood glucose readings of ¿103 mg/dl¿ with the subject meter and ¿over 300 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient stated that they manage their diabetes with a fixed dose of novolog insulin and indicated that they had recently been eating more.At the time of the initial call, the patient stated they knew their sugar was up and were experiencing ¿dry mouth and headaches¿.At the time of the follow-up call, the patient denied developing any other symptoms related to diabetes.It is unclear if the patient was symptomatic at the time the reading of ¿over 300 mg/dl¿ was obtained.There was no report of medical treatment/intervention received for an acute high blood glucose excursion after obtaining the alleged inaccurate low result.At the time of troubleshooting, the cca confirmed that an approved sample site was used for testing.The cca noted that the patient did not have control solution available to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms that could be that could be indicative of a serious injury adverse event while using the product.The alleged meter issue could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; 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: 15503725
• MDR Text Key: 300783993
• Report Number: 3008382007-2022-04349
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• 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: 09/28/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 09/29/2022
• 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): Life Threatening