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

Device Problem Device Handling Problem (3265)

Patient Problems Headache (1880); Nausea (1970); Diaphoresis (2452); Fluid Discharge (2686)

Event Date 12/11/2022

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.

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) alleging that his onetouch verio reflect meter displayed inaccurately high results compared to another meter.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the product issue started on december 10, 2022, at 10 pm.The patient claimed that he obtained a blood glucose reading of ¿255 mg/dl¿ with the subject device compared to a reading of ¿138 mg/dl¿ on a onetouch verio flex meter, within 30 minutes from each other.The patient manages his diabetes with a combination of diabetes medication (toujeo insulin 25 units if sugar is > 140 mg/dl and 10 units if sugar is < 140 mg/dl, once a day jardiance 25 mg, metformin 10 mg one in the morning and one at bedtime, ozempic 1 mg once a week) and he stated that he continued taking his usual medication in response to the alleged issue.The patient started developing symptoms of ¿gagging, cold sweat, nose running, feeling that he needs to throw up and headache¿ on (b)(6) 2022, at 3 am.The patient informed the cca that he self-treated the symptoms with sugar pills ¿to bring sugar up¿.The patient denied using any other device to check his blood glucose level.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood and he was following the correct testing procedure.However, the cca established that the test strips had been open beyond their discard date, expired, or stored improperly.The patient did not provide the test strip lot number.A replacement meter and a control solution 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 his usual diabetes medication 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: 16000611
• MDR Text Key: 305681585
• Report Number: 3008382007-2022-04362
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/16/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/16/2022
• 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 Age: 58 YR
• Patient Sex: Male