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

Lot Number 4776413

Device Problem Device Handling Problem (3265)

Patient Problem Shaking/Tremors (2515)

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) 2023, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio reflect meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began approximately 1-2 weeks prior to contacting lfs.The patient claimed obtaining blood glucose readings of ¿131 and 173 mg/dl¿ with the subject meter, performed within 20 minutes of each other.The patient manages their diabetes with unspecified insulin (12-14 units 3 times a day and 28-30 units at night, self-adjusted based on meter readings).As a result of the alleged issue, the patient reported increasing the insulin dose from 12-14 units to 16-20 units.After increasing the insulin dose, the patient reported experiencing ¿shakiness¿.The patient claimed they self-treated with food and felt better 15-20 minutes afterwards.The patient denied using any other device to test their blood glucose.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the same approved sample site was used for testing.The cca noted the patient was testing with test strips that had expired.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 after administering insulin based on alleged inaccurate results obtained with the subject meter.

• Brand Name: OT VERIO REFLECT 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: 17066351
• MDR Text Key: 316743159
• Report Number: 3008382007-2023-00028
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193475
• 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: 06/05/2023

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 Lot Number: 4776413
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/05/2023
• 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