MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4535423

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

Patient Problems Cramp(s) (2193); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio2 meter read inaccurately high compared to another meter (pharmacy meter).The complaint was classified based on the customer service agent (csa) documentation.The patient reported that the alleged inaccuracy issue began on (b)(6) 2019 when she started to obtain readings of over 200 mg/dl with the subject meter.The patient stated that she tests her blood glucose 3-4 times a day and that she manages her diabetes with a combination of levemir insulin and oral medication (metformin 1000 mg twice daily, farxiga 10 or 15 mg once daily, oseni once daily and glipizide 5 mg once daily).The patient claimed that as a result of the alleged inaccuracy issue, her online doctor advised to her to start increasing her insulin from 18 to 28 units.The patient reported developing symptoms of ¿muscle cramps and shaky hands¿ an unspecified time after the alleged issue began.The patient claimed that on (b)(6) 2019 she took an additional 5 units of insulin but when she still obtained a reading of ¿362 mg/dl¿ with the subject meter she proceeded to the pharmacy where her blood glucose was measured at ¿70 mg/dl¿ on the pharmacy device.The tests were performed within 30 minutes of each other.After the meter comparison, the patient attributed the symptoms to her blood glucose becoming low and claimed she had taken more insulin than necessary.At the time of troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter.The csa noted that an approved sample site was used for testing and that the correct testing process was being followed.The csa confirmed the test strip vial was intact and that the test strips had been stored correctly and were not expired or opened past their discard date.The csa 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 signs/symptoms suggestive of a serious injury adverse event after taking extra insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT VERIO 2 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: 9545404
• MDR Text Key: 173791333
• Report Number: 3008382007-2020-03833
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2019

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: 4535423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2019
• Initial Date FDA Received: 01/03/2020
• 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