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

Lot Number 4693261

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

Patient Problems Fatigue (1849); Hyperglycemia (1905); Dizziness (2194); Alteration in Body Temperature (4568)

Event Date 05/19/2022

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.

Event Description

On may 20, 2022, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio reflect meter read inaccurately low compared to a laboratory device.The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the patient and further information obtained when the medical surveillance specialist reviewed the call recording.During the follow-up call, the patient informed the cca that the alleged meter inaccuracy began in april 2022; she was unable to recall the exact date.The patient reported obtaining blood glucose readings of ¿5.8 mmol/l¿ with the subject meter and ¿28.3 mmol/l¿ on a laboratory device, performed within 1 hour of each other.The patient manages her diabetes with oral medication (metformin).During the initial call, the patient claimed she kept eating and eating as a result of the alleged issue and had been feeling terrible for the past week with symptoms of ¿dizziness, tiredness, weak and body heat increased¿.In response to the symptoms, the patient claimed she attended the pharmacy and was advised to contact her doctor.During the follow-up call, the patient confirmed that on (b)(6) 2022 she attended the doctor¿s office where a lab test was performed and the result of ¿28.3 mmol/l¿ was obtained.The patient claimed she was advised by her doctor to increase her dose of metformin from 500 mg three times a day to 1000 mg twice a day and additional blood work was performed.The patient denied receiving any other treatment and denied being taken to hospital.At the time of the follow-up call, the patient was still awaiting results of the blood work.During the follow-up call, the patient attributed the onset of the symptoms to the inaccurate low readings obtained on the subject meter and stated that had the meter read correct, she would have known how to manage her diet.At the time of troubleshooting, the cca noted the correct testing process was being followed.The cca confirmed the test strip vial was intact and that the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged meter inaccuracy began.The subject meter 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
• 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: 14545180
• MDR Text Key: 293266877
• Report Number: 3008382007-2022-04312
• 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: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4693261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2022
• 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