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

Lot Number 4695733

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

Patient Problems Hypothermia (1915); Dizziness (2194); Dysphasia (2195); Shaking/Tremors (2515)

Event Date 01/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the reporter of the patient/lay user contacted lifescan (lfs) uk by email alleging that her mother¿s onetouch verio2 meter read inaccurately high compared to their feelings and/or normal results.The complaint was classified based on the customer care agent (cca) documentation.The reporter alleged that the issue began on (b)(6) 2021, around lunch time.The reporter claimed that the patient obtained a blood glucose reading before lunch of ¿17.8 mmol/l¿ and after lunch she obtained a reading of ¿22.3 mmol/l¿ with the subject meter.In the evening, before dinner, the patient obtained a reading of ¿14.7 mmol/l¿ with the subject meter.The reporter informed the cca that her mother manages her diabetes with a combination of toujeo and humalog insulin (self-adjusted) and claimed that she increased her usual dose of humalog insulin with 4 units due to the high reading before dinner.The following morning ((b)(6) 2022) the patient did her usual 2 tests and received before breakfast a reading of ¿17.5 mmol/l¿ and 2 hours after breakfast a reading of ¿17.9 mmol/l¿ with the subject meter.Again, the patient increased her usual dose of humalog insulin with 6 units due to the high reading before breakfast.The reporter claimed that her mother felt ¿a bit hypoglycemic¿ and went to sleep for 4 hours.The patient woke up around 4 pm, did a test on the subject meter and received a blood glucose reading of ¿13.5 mmol/l.¿ the patient took her usual 6 units of humalog insulin and the reporter stated that her mother did not feel good afterwards.The patient decided to call her daughter, who said that her mother was not making any sense and was ¿incoherent¿ and had developed symptoms of ¿shaking, hypothermia (body temperature of 32 degrees) and dizziness¿.Around 5 pm the daughter treated her mother with some food and took her to the hospital where around 9 pm a blood glucose reading of ¿12.9 mmol/l¿ on a hospital meter was obtained compared to a reading of ¿23.9 mmol/l¿ on the subject meter.No other medical treatment has been reported.During troubleshooting, the cca established that the unit of measure was set correctly on the subject meter.The test strips had been stored properly, were not open beyond their discard date and had not expired.The cca noted that the patient did not have control solution available at the time of the call to test the subject device.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking increased doses of insulin based on alleged inaccurate high results obtained with the subject meter.

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.

• 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
• 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: 13350029
• MDR Text Key: 286764728
• Report Number: 3008382007-2022-04288
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K131363
• 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: 01/25/2022

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: 4695733
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 01/25/2022
• 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: 81 YR