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

Lot Number 4833901

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Anxiety (2328); Shaking/Tremors (2515)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

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, 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.

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) (b)(6) , alleging that their onetouch verio reflect meter was reading inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on information obtained by the customer care agent (cca) during the initial call, since the patient disconnected the call during a follow-up attempt.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿10.0, 14.0 and 16.0 mmol/l¿ with the subject meter at unspecified dates/times.It was not reported what medication the patient takes to manage their diabetes.In response to the alleged issue, the patient indicated they took action to increase or change their medication.As a result, the patient reported developing ¿low blood sugar¿ and started ¿shaking¿ and having a "panic attack¿.There was no report of medical treatment/intervention received as a result of the alleged issue.At the time of the follow-up call, the patient indicated they had recovered well.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after making changes to their usual diabetes management based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT VERIO REFLECT 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: 15547371
• MDR Text Key: 301236862
• Report Number: 3008382007-2022-04351
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4833901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• 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