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

Model Number 023-271

Device Problem Device Handling Problem (3265)

Patient Problems Anxiety (2328); Shaking/Tremors (2515)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition to this, 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.

Event Description

On (b)(6)2023, a patient contacted lifescan (lfs) us alleging that they were receiving inaccurate high results on their ot verio flex meter compared to how they were feeling.The complaint was classified based on the customer care agent (cca) documentation.The patient stated that on (b)(6) 2023, they obtained results of ¿98mg/dl¿ and ¿223mg/dl¿ on the device.No times were provided for these results however it was noted that the results were ¿within hours¿.These meter readings were taken outside the set time limit to determine if there is a meter problem.The patient developed symptoms they described as ¿hands shaking¿ and ¿nervousness¿.The patient was unwilling to provide further details of the incident or of their usual diabetes treatment regimen.No further information was provided and attempts to contact the customer to gather further information regarding this complaint were unsuccessful.During troubleshooting, the cca performed a control solution test with the patient and obtained a result of ¿121mg/dl¿, this is within the labelled range of 102mg/dl ¿ 138mg/dl determined that the test strips were within expiry and the vial was not cracked or broken.A replacement device was sent to the patient.Although there are few details for this alleged incident, this complaint is being reported because the patient allegedly developed signs/symptoms suggestive of a serious injury adverse event and the subject device cannot be ruled out as a cause or contributory factor.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 17190604
• MDR Text Key: 317754476
• Report Number: 3008382007-2023-00036
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• 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
• Report Date: 06/23/2023

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 Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 5619710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/23/2023
• 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