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

Lot Number 5648152

Device Problem Device Handling Problem (3265)

Patient Problem Extreme Exhaustion (1843)

Event Date 03/23/2024

Event Type  Injury  

Event Description

On march 25, 2024, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio reflect meter was reading inaccurately low compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged issue started on (b)(6) 2024, in the morning.The patient stated that she usually gets blood glucose readings in the range of ¿150 mg/dl¿.That morning, even though the patient could not remember the exact reading from the subject meter, she claimed it was in her usual range.The patient manages her diabetes with metformin 500 mg and continued taking her usual dose in response to the alleged issue.At 11 am the patient started feeling ¿exhausted¿ and felt ¿so bad¿ that she had to go to the emergency room (er).At 11:30 am a blood glucose reading of ¿208 mg/dl¿ was obtained on an er meter.The patient received an unspecified type and dose of insulin at the er provided by a health care professional (hcp).During troubleshooting, the cca confirmed that the patient obtained the blood sample from an approved sample site.The cca noted that the patient did not have control solution at the time of the call to test the subject system and explained to the patient how to use control solution.The cca established that the test strips had not 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 she received alleged inaccurate low results with the subject meter and reportedly received hcp treatment for an acute high blood glucose excursion after using the product.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 REFLECT METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; 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: 19093970
• MDR Text Key: 339986184
• Report Number: 3008382007-2024-00019
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5648152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• 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; Required Intervention