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 Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

On february 06, 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio flex meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that they first became aware of the alleged meter inaccuracy on the morning of (b)(6) 2021, around 8:30 to 9:30 am, just after they were discharged from hospital.The patient reported obtaining blood glucose readings of ¿110, 142, 142, 129 and 116 mg/dl¿ with the subject meter, performed more than 20 minutes apart.The patient stated that they manage their diabetes with a combination of medication (metformin twice daily; trulicity once weekly) and denied making any changes to their usual diabetes management regimen as a result of the alleged issue.The patient reported developing symptoms of feeling ¿shaky, tremors and confused a little bit¿ around (b)(6) 2022 (they were unable to recall the exact date and time).In response to the symptoms, the patient claimed they ate small pieces of fruit.The patient reported that their blood glucose measured ¿111 mg/dl¿ on another device after treatment.At the time of troubleshooting, the cca noted the same approved sample site was used for testing.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 the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

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.

• 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: 13502348
• MDR Text Key: 286764870
• Report Number: 3008382007-2022-04290
• 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: 02/09/2022

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
• Device Lot Number: 4782341
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 02/09/2022
• 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