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

Lot Number 4762097

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

Patient Problems Irritability (2421); Diaphoresis (2452); Lethargy (2560)

Event Date 02/07/2022

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.In addition, 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 reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that her daughter¿s onetouch verio reflect meter displayed inaccurately erratic blood glucose results.The complaint was classified based on the customer care agent (cca) documentation.The reporter alleged that the product issue began on (b)(6) 2022, at approximately 5:40 pm.The reporter informed that the patient obtained blood glucose readings of ¿214 and 113 mg/dl¿ on the subject meter, within 20 minutes of each other.The reporter stated that her daughter is epileptic and manages her diabetes with humalog insulin (fixed dose 14 corrections per carb) and claimed that she administered more insulin (dose and time given unspecified) to her daughter in response to the alleged issue because she did not realize that the subject meter was reading inaccurate.At an unspecified time after the alleged issue occurred, the patient started developing symptoms of ¿tired, irritable and sweating¿.The reporter claimed that she bought a generic meter from (b)(6), which she used to test on february 3 or 4, 2022, and then realized her daughter¿s blood glucose was too low.She treated her daughter with a juice box and checked 15 minutes later her blood glucose again to find that it was still low.The reporter did not specify the readings.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.The cca noted that the patient did not have control solution to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.A replacement meter was 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 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: 13518867
• MDR Text Key: 287346934
• Report Number: 3008382007-2022-04293
• 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: 02/11/2022

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
• Device Lot Number: 4762097
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/11/2022
• 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