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

Model Number 023-271

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

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Syncope/Fainting (4411)

Event Date 09/28/2022

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.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.

Event Description

On (b)(6) 2022, the patient/lay user contacted lifescan (lfs) usa alleging that her onetouch verio flex meter read inaccurately high compared to her feelings and/or normal results.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that alleged issue began on (b)(6) 2022, at an unspecified time.The patient claimed that the subject meter gave her different readings and continued to give her higher readings.The patient stated she then bought a control solution, tested, and received a reading of ¿236 mg/dl¿ with the subject meter.On (b)(6) 2022, before breakfast at 8:56 am, the patient received a blood glucose reading of ¿131 mg/dl¿ on the subject meter.The patient manages her diabetes with three types of insulin (ozempic ¿ once a week, novolog at mealtimes and basaglar in the evening) and she stated that she increased her novolog insulin by 3 units in response to the alleged issue.Approximately 15 minutes later, at 9:13 am, the patient ¿fainted¿ and hit her head on the table.The patient also started to feel ¿sweaty and had a big rush¿ and stated that she ¿crashed¿.The patient reported that she self-treated with orange juice and went to lay down on the sofa, immediately after the symptoms appeared.The patient denied using any other device to test her blood glucose.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device at the time of testing.The cca established that the test strips had been stored properly, were not open beyond their discard date, not expired and the test strip vial was not cracked or broken.Replacement products 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 an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT VERIO FLEX 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: 15665980
• MDR Text Key: 302339997
• Report Number: 3008382007-2022-04353
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4879987
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• 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 Sex: Female