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

Lot Number 5714863

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Limb Fracture (4518); Vertebral Fracture (4520)

Event Date 11/28/2023

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.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 december 15, 2023, the lay user/patient contacted lifescan (lfs) canada, alleging that his onetouch verio reflect meter was reading inaccurate compared to his feelings and/or normal readings and inaccurately high compared to another device (ems meter).The complaint was classified based on the customer care agent (cca) documentation, since the patient was unable to be reached by phone for additional information.The patient reported that the alleged meter inaccuracy began on november 28, 2023, at 6:05 am.The patient reported obtaining an alleged inaccurate result of ¿4.0 mmol/l¿ with the subject meter when he woke up before starting to prepare for work.In response to this result, the patient stated that he treated himself per treatment protocol established with his medical care team, to get his blood sugars above 5.0 mmol/l to be able to drive.Per treatment protocol, he took 25 grams of carbohydrates then 3 units of humalog insulin along with 78 grams of carbohydrates.He stated that this protocol has worked for him.It was not reported if the patient re-tested his blood glucose before driving.The patient claimed that as a result of relying on the ¿4.0 mmol/l¿ result, he had an accident at around 6:45 am that morning that led to a ¿broken ankle and fractured lumbar¿.The patient mentioned he was not feeling well a moment prior to the accident and had attempted to pull over safely.The patient stated that emergency medical services (ems) arrived at around 7:00 am and took him to the hospital.The patient stated that a blood glucose test was performed on the ems meter and a result of ¿2.5 or 2.7 mmol/l¿ was obtained.No further information was provided.At the time of troubleshooting, the cca confirmed the correct test trips were being used, the test strip vial was intact, and the test strips had been stored correctly and were not expired.The cca noted the patient did not have control solution available to perform a quality control test.The patient declined to complete the troubleshooting process.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 requiring medical intervention after the alleged meter inaccuracy began.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 18370985
• MDR Text Key: 331051234
• Report Number: 3008382007-2023-00075
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2023

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: 5714863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/21/2023
• 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; Required Intervention