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 Vertigo (2134); Shaking/Tremors (2515)

Event Date 10/16/2021

Event Type  Injury  

Manufacturer Narrative

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) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter read inaccurately erratic compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained after customer care (cc) reviewed the initial call with the patient.The patient reported that the alleged meter inaccuracy began approximately 15 days prior the call to lfs around (b)(6) 2021, at an unspecified time.The patient reported that since that time she obtained alleged inaccurate high blood glucose readings of ¿290 and 230 mg/dl¿ at fasting, ¿300 and 290 mg/dl¿ at dinner time and ¿420 and 320 mg/dl¿ before bedtime.The patient manages her diabetes with insulin (humalog ¿ 50 units and basaglore ¿ 45 units) and indicated that during those 15 days she stopped eating carbs and took insulin based on the meter results.At an unspecified time after the alleged issue occurred the patient started to feel ¿shaky¿.The patient claimed that she treated herself with her usual dosage of insulin (humalog ¿ 50 units and basaglore ¿ 45 units).The patient denied using any other device to test her blood glucose.Follow up with cc confirmed that the patient also felt ¿dizzy¿ and that she started experiencing the symptoms after she treated herself with more insulin.No other medical treatment was reported.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.A control solution and test strips have been sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after reducing her carb intake and taking insulin based on alleged inaccurate results obtained with the subject meter.

• 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: 12783656
• MDR Text Key: 281198212
• Report Number: 3008382007-2021-04268
• 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: 11/09/2021

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: 4646177
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2021
• Initial Date FDA Received: 11/09/2021
• 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