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

Lot Number 4836117

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Convulsion/Seizure (4406)

Event Date 11/08/2022

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) 2022, the lay user/patient contacted lifescan (lfs) canada, alleging that their onetouch verio reflect meter was reading inaccurately high compared to a continuous glucose monitoring device (cgm).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on the morning of (b)(6) 2022, at 11:00 am.The patient claimed obtaining a reading of ¿3.2 mmol/l¿ with the cgm device then ¿10.2 mmol/l¿ on the subject meter.The patient stated that prior to the alleged issue, they began having a seizure and proceeded to check their glucose with the assistance of a third-party (lay individual).The patient manages their diabetes with long-acting insulin (tresiba) and fast-acting insulin (admelog).When the reading of ¿10.2 mmol/l¿ on the subject meter was obtained, the patient claimed they trusted the meter and took action by administering an increased dose (15 units) of admelog insulin.At around 11:30 am that morning, the patient¿s seizure worsened, and a third-party (lay individual) treated them with glucose gel followed by honey, sugar and dextrose.The patient stated that they re-checked their glucose at 12:00 pm when they felt well, and obtained a reading of ¿5.4 mmol/l¿ with the cgm device compared to a reading which was ¿3 units apart¿ on the subject meter.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca confirmed the test strip vial was intact, the test strips had been stored correctly and the correct testing process was being followed.However, the patient was unable to recall if the test strip vial had been opened for longer than the discard date.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed worsening symptoms suggestive of a serious injury adverse event after administering insulin based on an alleged inaccurate result 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: 15832645
• MDR Text Key: 303996915
• Report Number: 3008382007-2022-04356
• 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: 11/21/2022

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 Lot Number: 4836117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/21/2022
• 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; Required Intervention
• Patient Age: 35 YR