OT VERIO FLEX METER 023-271

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for OT VERIO FLEX METER 023-271 manufactured by Lifescan Europe Gmbh.

Event Text Entries

[186724596] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[186724597] On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioflex meter was reading inaccurately high compared to their feelings and/or normal readings. The complaint was classified based on information obtained from the customer service representative (csr) documentation. The patient reported that the alleged issue began around 10-11 a. M. , on an unspecified date approximately 3 months prior to contacted lfs. The patient manages their diabetes with a combination of oral medication (metformin, 100 mg twice daily) and insulin (sliding scale). The patient reported that prior to the alleged inaccuracy issue beginning, he developed symptoms of? Sweating, bottoming out? And that he? Felt like passing out?. The patient advised that in response to the symptoms he developed that he tested his blood glucose with the subject device and claimed obtaining a blood glucose result that was? Above 100 mg/dl? And that he felt this was inaccurately high in comparison to how he was feeling. The patient reported that approximately 15 minutes later, he tested with another device (onetouch ultra2), claimed obtaining a blood glucose result of? 40 mg/dl? And that his wife then treated him with a soda. The patient reported that following treatment, his blood glucose levels began to rise; however, no further blood glucose results were provided. At the time of troubleshooting, the csr confirmed that the unit of measure was set correctly at the time of testing and noted that the patient did not have control solution available in order to test the subject device. Replacement products were sent to the patient. This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event whilst using the subject device and required treatment from a third party for an acute low blood glucose excursion. The alleged inaccuracy issue could not be ruled out as a cause and/or contributor to the event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008382007-2020-03886
• MDR Report Key: 9896757
• Report Source: CONSUMER
• Date Received: 2020-03-30
• Date of Report: 2020-03-26
• Date Mfgr Received: 2020-03-26
• Date Added to Maude: 2020-03-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SIMON PALMER
• Manufacturer Street: BEECHWOOD PARK NORTH
• Manufacturer City: INVERNESS IV2 3ED
• Manufacturer Country: GB
• Manufacturer Postal: IV2 3ED
• Manufacturer Phone: 1463383679
• Manufacturer G1: LIFESCAN SCOTLAND
• Manufacturer Street: BEECHWOOD PARK NORTH
• Manufacturer City: INVERNESS IV2 3ED
• Manufacturer Country: GB
• Manufacturer Postal Code: IV2 3ED
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OT VERIO FLEX METER
• Generic Name: GLUCOSE MONITORING SYS/KIT
• Product Code: NBW
• Date Received: 2020-03-30
• Model Number: 023-271
• Catalog Number: 023-271
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LIFESCAN EUROPE GMBH
• Manufacturer Address: GUBELSTRASSE 34 ZUG 6300 CH 6300

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-30
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2020-03-30