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

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

Patient Problems Syncope (1610); Blurred Vision (2137); Loss of Vision (2139); Weakness (2145); Confusion/ Disorientation (2553)

Event Date 10/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) france, alleging that his onetouch verio2 meter displayed inaccurately high results compared to his feelings/normal results.The complaint was classified based on the customer service representative (csr) documentation following a review of the call.The patient reported that he had the subject meter for about a month, after previously using a different brand of meter.He stated that at 7pm on (b)(6) 2019, he was feeling ¿a bit tired¿, so checked his blood glucose level on the subject meter and obtained a reading of ¿138 mg/dl¿; he reported that he considered this result high compared to his feelings/normal results.The patient manages his diabetes with a combination of four types of insulin (actrapid, insulatard, novorapid and novomix 50) which he self-adjusts.He reported that after obtaining the result, he made no changes to his usual diabetes management routine, did not administer any medication and went to sleep.He indicated that he woke up at 9pm on (b)(6) 2019, with symptoms of ¿couldn¿t see, blurred vision, couldn¿t recognize where he was, troubled, disturbed and no strength¿.He also reported ¿je me sentais partir¿ which has been interpreted as ¿i felt myself leaving or felt like i was passing out¿.He reported that he self-treated his symptoms by eating a few grapes and he began to feel better about 10 minutes later.He denied using any other meter to test his blood glucose levels.During troubleshooting, the csr noted that the patient¿s meter was set to the correct unit of measure.The csr established that contrary to the owner¿s booklet, the patient did not routinely wash his hands before performing blood tests and only changed the lancing device about every 15 days rather than before each new blood test.Training was provided by the csr.The patient had thrown away the test strips involved in the allegation and was unable to provide details of the test strip lot number.The patient did not have control solution to test the meter and test strips and a replacement meter and control solution were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after obtaining an alleged inaccurately high blood glucose result on the subject meter and following his usual diabetes management routine.

Manufacturer Narrative

The subject meter was returned by the patient.The meter passed testing and the alleged issue could not be confirmed.A dhr review was performed which did not identify anything in the manufacturing process which could affect product performance.As the patient did not provide the test strip lot number, no lot evaluation could be performed.

• 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
• MDR Report Key: 9201938
• MDR Text Key: 164001338
• Report Number: 3008382007-2019-03794
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR