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

Lot Number 4350276

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Sweating (2444)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the meter issue begun a month prior to her contacting lfs.She reported that, on (b)(6) 2018 around 4 am, she had obtained an alleged inaccurate high blood glucose reading on the subject meter, of ¿267 mg/dl¿.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient reported that she manages her diabetes with insulin (self-adjuster), and in response to the alleged meter issue she had increased her humalog insulin (dose unknown).The patient reported that shortly after administering the insulin, she developed symptoms of ¿face dripping wet and drenched¿.In response to the symptoms around 5 am on (b)(6) 2018, she self-treated by eating something and drinking some milk.During troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter, and that the patient¿s test strips had been stored correctly, were within expiry date.The csr noted the patient did not have control solution.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms of a serious injury adverse event while using the subject meter.There is insufficient information to rule out the contribution of the subject meter to the event.

Manufacturer Narrative

The lay user/patients 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.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7649445
• MDR Text Key: 112704533
• Report Number: 3008382007-2018-01841
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150214
• 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,Followup
• Report Date: 06/28/2018

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: 4350276
• Other Device ID Number: 1-3BBSA4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/28/2018
• Device Age: 25 MO
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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