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 Dehydration (1807); Dizziness (2194); Shaking/Tremors (2515); Presyncope (4410)

Event Date 10/31/2022

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.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 Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was displaying inaccurate readings.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the subject meter started reading inaccurate on (b)(6) 2022 at 11:53 pm.The patient obtained a blood glucose reading of ¿109 mg/dl¿ on the subject meter.The patient also reported blood glucose readings of ¿102 mg/dl¿ on november 01, 2022 and ¿119 mg/dl¿ on (b)(6) 2022 with the subject meter.The patient manages her diabetes with metformin pills (dosage unspecified) and she claimed that she drank a lot of water, ate a yogurt and drank some milk in response to the reading of (b)(6) 2022 at 11:55 pm.The patient stated that at that same time, after the alleged issue occurred, she developed symptoms of ¿dizzy, dehydration, feels out of herself, shaking¿ and ¿felt she was going to pass out¿.The patient indicated that she drank more water however, she denied receiving any medical treatment for the reported symptoms.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples.The cca noted that the patient did not have control solution at the time of the call to test the subject system.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while using the product.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.Further analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 15802114
• MDR Text Key: 303702208
• Report Number: 3008382007-2022-04355
• 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,Followup
• Report Date: 03/20/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4728576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female