MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO FLEX METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4367742

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

Patient Problems Paralysis (1997); Dysphasia (2195)

Event Date 08/24/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 the lay user/patient contacted lifescan (b)(4) alleging that his onetouch verio flex meter was reading inaccurately high compared to his feelings and/or usual results.The complaint was classified based on the customer service representative (csr) documentation.The patient stated that the alleged inaccuracy issue began at 01:00am on (b)(6) 2018 when he obtained a blood glucose result of 278 mg/dl (from memory) using the subject device, which he felt was elevated compared to his feelings and/or usual results.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient stated that he manages his diabetes using insulin and self-adjusts the dose and took an additional 3 units of ¿actrapid¿ in response to the reading obtained.The patient stated that he experienced symptoms of ¿signs of paralysis and speech problems¿ approximately 15 minutes after the alleged issue began.The emergency services (ems) were called, and the patient received hcp treatment of iv glucose after a result of ¿40 mg/dl¿ was obtained using the ems meter, at 01:25am on (b)(6).At the time of troubleshooting, the csr determined that the unit of measure was set correctly at time of testing, and the test strips had been stored correctly and within expiry.The csr noted that the patient did not have any control solution.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury adverse event after the alleged product issue began.

Manufacturer Narrative

The lay user/patient's meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter passed all testing with no faults found.The reported issue could not be confirmed.Lifescan also conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7825756
• MDR Text Key: 118526698
• Report Number: 3008382007-2018-02408
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4367742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/27/2018
• Device Age: 31 MO
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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: 65 YR