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

Device Problem Component Missing (2306)

Patient Problem Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio iq meter kit was missing an adapter.The complaint was classified based on the customer service representative (csr) documentation.The patient was unable to specify when she first noticed that the meter adapter was missing.The patient manages her diabetes with a self-adjusted dose of insulin (usual dose 22 units) and reported that due to the product issue she had to guess how much insulin to take.The patient reported that an unknown time after the product issue first began she developed a symptom of feeling ¿shaky¿.The patient reported self-treating this symptoms with juice and taking a candy.During troubleshooting, the csr confirmed that the closure seal on the packaging was intact prior to opening.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event after being unable to charge her meter due to the ac adaptor being missing from her verio iq meter kit.

• Brand Name: OT VERIO IQ METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8136697
• MDR Text Key: 129435346
• Report Number: 3008382007-2018-03362
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885007702
• UDI-Public: 00353885007702
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K110637
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2018
• Date Manufacturer Received: 11/28/2018
• 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; Required Intervention