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 inaccurate compared to her normal results.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, she had obtained an alleged inaccurate blood glucose reading on the subject meter, of ¿129 mg/dl¿.The patient reported that she manages her diabetes with insulin (self-adjuster.The patient reported that after the meter issue began, she developed symptoms of ¿sweating¿.In response to the symptoms around 11 pm on (b)(6) 2018, she self-treated by taking 3 tablespoons of chocolate syrup.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.

• 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: 7649444
• MDR Text Key: 112705477
• Report Number: 3008382007-2018-01840
• 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: Other Caregivers
• Type of Report: Initial
• 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?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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