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 Problem Shaking/Tremors (2515)

Event Date 05/08/2023

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) 2023, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and based on information obtained after customer care (cc) followed up with the patient by phone.The patient alleged that the product issue began approximately 2 weeks prior to the initial call with lfs, at an unspecified time.The patient reported that she started using her new meter during a vacation and received higher readings than she usually does.The patient claimed that she obtained blood glucose readings of ¿200-250 mg/dl¿ on the subject meter.The patient manages her diabetes with basaglar insulin (10 units twice a day) and stated that at doctor¿s advice she increased her insulin intake by 1 unit in response to the alleged issue.The patient indicated that she was taking the increased amount of insulin for 2-3 days and noticed that her blood sugar level did not go down.The patient then checked her glucose levels on her neighbor¿s onetouch verio flex meter and obtained a reading of ¿59 mg/dl¿.Immediately after, she re-tested and received a reading of ¿180 mg/dl¿ on the subject meter.The patient reported that she started ¿shaking¿ because her sugar was low without her knowing it.The patient denied receiving any medical treatment for the reported symptoms.However, approximately 20 minutes later she went to walmart to check her glucose levels and received a reading of ¿133 mg/dl¿ on an unspecified meter.The patient indicated that the reading was not too high for her, bought another meter and stopped taking the 11 units of insulin.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had used an approved sample site to obtain the blood samples.The patient was following the correct testing procedure, however, the cca established that the test strips were not stored properly since the patient had taken them out of the vial.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 alleged inaccurate high results obtained with the subject meter.

Manufacturer Narrative

The lay user/patient¿s meter has 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.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: 17084035
• MDR Text Key: 316750432
• Report Number: 3008382007-2023-00030
• 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: 09/11/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/11/2023
• 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