MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4647038

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

Patient Problems Fatigue (1849); Dizziness (2194); Dysphasia (2195); Pallor (2468); Shaking/Tremors (2515); Cognitive Changes (2551)

Event Date 12/14/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) united kingdom, alleging that his onetouch verio2 meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient informed the cca that the alleged meter inaccuracy began around (b)(6) 2020.The patient reported obtaining alleged inaccurate high readings of ¿22.4, 18.3, 14.0, 14.5, 17.4, 17.0, 22.3, 18.4, 27.4, 16.0, 16.3, 20.5, 16.3, 16.9, 16.8, 22.5, 15.1, 15.4 and 19.8 mmol/l¿ with the subject meter on separate occasions.The patient manages his diabetes with a combination of humalog and lantus insulin on a self-adjusting dose based on food intake.It was not reported if the patient made any changes to his usual diabetes management regimen in response to the elevated results.The patient reported experiencing ¿hypoglycemia¿ with symptoms of ¿light-headedness, shakiness, cannot concentrate, cannot speak, very weak and very pale¿ almost every night since the alleged issue began; he was unable to recall exact dates/times.The patient reported treating himself with an energy drink in response to the symptoms.On (b)(6) 2020, the patient reported receiving advice from his diabetes nursing team to reduce his dose of insulin from 56 to 44 units.The patient denied using any other device to test his blood glucose.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted that the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correct 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 product was 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 inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.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.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11108013
• MDR Text Key: 231126838
• Report Number: 3008382007-2021-04090
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: 4647038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening