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

Lot Number 4504030

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

Patient Problems Hyperglycemia (1905); Collapse (2416)

Event Date 10/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a reporter for the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch verioflex meter read inaccurately low compared to her feelings and/or normal readings.The complaint was classified based on the customer service agent (csa) documentation.The csa was advised by the reporter that on the morning of (b)(6)2019 (exact time not reported), the patient obtained a fasting blood glucose reading of ¿62 mg/dl¿ with the subject meter.The reporter claimed the patient took breakfast then re-tested with the subject meter obtaining a result of ¿38 mg/dl¿.The reporter stated that the patient manages her diabetes with oral medication (amaryl once daily after breakfast).In response to the low results, the reporter contacted the doctor by phone and was advised to give the patient lemon juice and sweets.The reporter claimed that after treatment (exact time not reported), the patient¿s blood glucose was further tested with the subject meter and a result of ¿32 mg/dl¿ was obtained, at which point the patient reportedly started ¿collapsing¿ and was immediately taken to the emergency room.The reporter claimed the patient was initially given ¿saline¿ then her blood glucose was measured at ¿498 mg/dl¿ on the hospital meter and was treated with insulin (type/dose not reported).The patient was reportedly discharged after 10 hours.At the time of troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter.The csa noted the patient did not have control solution available to perform a quality control test.The csa noted the patient was testing with test strips that were stored correct and were not expired or opened past their discard date.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical treatment for an acute high blood glucose excursion after taking food based on alleged inaccurate low results obtained with the subject meter.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: michelle karim ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED
• MDR Report Key: 9196898
• MDR Text Key: 162476451
• Report Number: 3008382007-2019-03793
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4504030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• 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: 60 YR