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

Lot Number 4859765

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

Patient Problems Nausea (1970); Paresis (1998); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 08/25/2022

Event Type  Injury  

Event Description

On august 26, 2022, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch verio flex meter was reading inaccurately high compared to his feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter alleged that the product issue began on (b)(6) 2022 at 5 pm.The reporter claimed that the patient obtained a blood glucose reading of ¿587 mg/dl¿ on the subject meter.The patient manages his diabetes with an unspecified insulin (self-adjusting dose, twice a day) and the reporter stated that the patient increased his insulin intake with an unspecified dose at 5:10 pm in response to the high readings.The reporter informed the cca that at 7 pm that same day, the patient started to develop symptoms of ¿confusion, nausea, can¿t get up and sweating¿.The reporter claimed that the patient was treated with glucose tablets/glucose gel, provided by another person at 7:10 pm.At 7:00 pm, before treatment, a blood glucose reading of ¿41 mg/dl¿ was obtained on another unspecified meter.The reporter indicated that the patient felt better a few minutes after treatment.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure.The cca confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The patient did not have control solution available to test the subject meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on an alleged inaccurate high result obtained with the subject meter.

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.

• 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: 15466245
• MDR Text Key: 300400371
• Report Number: 3008382007-2022-04347
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K193475
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4859765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2022
• 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
• Patient Sex: Male