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

Lot Number 4728574

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Dyspnea (1816); Fatigue (1849); Tachycardia (2095); Diaphoresis (2452)

Event Date 08/30/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio reflect meter was displaying an error message of ¿error 4¿ and ¿error 2¿.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained after the medical surveillance specialist reviewed the call recording.The patient reported that the alleged error messages began to appear on (b)(6) 2021, at 4 pm.At 5 pm that same day the patient tested again and obtained a blood glucose reading of ¿404 mg/dl¿ on the subject meter.The patient tests her blood glucose four times a day and manages her diabetes with oral medication (glipizide and metformin ¿ dose unspecified) and stated that she went to the pharmacy where they provided her with glipizide to ¿revert the effect of the reading¿.On (b)(6) at 7 am the patient developed symptoms of ¿sweaty palms, high beating heart, shortness of breath and feeling weak¿.The patient indicated that she did not take any of her regular medication because she still was unable to get a reading, but instead went to the emergency room (er) at 9 am.A fasting blood glucose reading of ¿119 mg/dl¿ was obtained on an er meter at 1 pm.The patient got discharged from the er at 5 pm and at 6 pm she ate fish and soup along with her medication (1000 mg metformin, 10 mg glipizide and 25 mg jardiance).No other medical treatment was reported.At the time of troubleshooting, the customer care agent (cca) noted the subject meter was not being used for the first time and the issue remained unsolved.The cca established that the error was caused by the system.Replacement products were sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive indicative of a serious injury adverse event after the alleged meter issue began and the device could not be ruled out as a cause or contributor to the event.

• 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
• MDR Report Key: 12523784
• MDR Text Key: 278763706
• Report Number: 2939301-2021-02954
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4728574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening