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

Lot Number 4774100

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Shaking/Tremors (2515); Salivary Hypersecretion (4486)

Event Date 07/01/2022

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¿s mother (reporter) contacted lifescan (lfs), alleging that the patient¿s onetouch verio reflect meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred on (b)(6) 2022, at 11:53 pm when they measured the patient¿s blood glucose with the subject meter and received an alleged high result of ¿10.3 mmol/l¿.A normal expected result for the patient is ¿5.9 mmol/l¿.The patient manages their diabetes with insulin on a self-adjusting dose (usually 15-18 units in a day, but sometimes it can be different) and their blood glucose is usually measured 6-10 times a day.In response to the elevated reading of ¿10.3 mmol/l¿, the reporter gave the patient an injection of 1 unit of novorapid short-acting insulin.At 1:25 am the following morning, the patient experienced symptoms of ¿shaking¿, ¿foaming at the mouth¿ and ¿loss of consciousness¿.The reporter immediately measured the patient¿s blood glucose with the subject meter and received a result of ¿3.9 mmol/l¿.At the same time, they received a result of ¿1.9 mmol/l¿ with a continuous glucose monitoring device.The reporter treated the patient with a glucagen injection and contacted emergency medical services (ems) for assistance.When an ambulance arrived 15 minutes later, the patient¿s blood glucose measured ¿1.0 mmol/l¿ on the ems meter.The patient was transported to hospital where they were treated with intravenous glucose.The reporter advised that prior to the reported issue, the patient had last consumed food at 8:22 pm on (b)(6) 2022, and the blood glucose measurement result received after eating was ¿9.1 mmol/l¿ on subject meter.The reporter denied the patient used any other meter during the time of concern.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject.The cca noted the test strips were stored correct and were not expired or opened past their 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 received medical intervention for an acute low blood glucose excursion after insulin was administered based on an alleged inaccurate high 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: 15992929
• MDR Text Key: 305585391
• Report Number: 3008382007-2022-04361
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4774100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• 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): Required Intervention; Life Threatening
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 32 KG