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

Lot Number 4558399

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

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Hemorrhage/Bleeding (1888); Pneumonia (2011)

Event Date 08/03/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioflex meter displayed inaccurately erratic results and error messages.The complaint was classified based on the customer care advocate (cca) documentation following a review of the call by a senior cca.The patient reported that she started experiencing problems with the meter during the first week of (b)(6) 2019, when she obtained alleged inaccurately erratic blood glucose results as high as 600 mg/dl and as low as 50 mg/dl, while on other occasions she obtained error messages (error number not known).The patient manages her diabetes with a combination of insulin ¿ admalog (4-20 units), trulicity and 30 units of basaglar if she gets a very high reading.She reported that when she obtained low readings, she ate a sandwich and when she got high readings, she administered admalog (4-20 units).She stated that on (b)(6) 2019, she developed symptoms of ¿cannot breathe, blood clot in the lung, continuous bleeding and pneumonia¿.The patient stated this was caused by the fact that her blood sugar was out of control which, she alleged, was caused by the meter giving inaccurate readings and error messages.The patient reported that she was treated in the icu and spent the month of august in hospital where, amongst other things, she was treated with insulin.At the time of troubleshooting, the cca noted that the subject meter was set to the correct unit of measure and the samples had been taken from the same approved sample site.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event requiring medical intervention after obtaining alleged inaccurately erratic results and error messages on the subject meter and continuing with her usual diabetes management routine of insulin sliding scale.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 9368068
• MDR Text Key: 168600870
• Report Number: 2939301-2019-02544
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4558399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention