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 Paresis (1998); Loss of consciousness (2418); Hypoglycemic Shock (4575)

Event Date 04/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verioflex meter was reading inaccurately.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that at 12:00 a.M., on (b)(6) 2022, they ¿started feeling symptoms¿; however, they were unable to provide specific details regarding the symptoms they developed.The patient advised that in response to the symptoms, they tested their blood glucose using the subject device, reporting that the device may have given a ¿wrong reading¿ though, they could not recall the result obtained.The patient manages their diabetes with a combination of insulin (novolog 1-20 units, self-adjusting and, levimir, 60 units) and oral medication (gliclazide, 1 pill unspecified dose) and the patient reported that in response to the reading obtained, they administered their medication as usual.The patient reported that an unspecified time later, he developed ¿diabetic shock¿; advising that he ¿could not move at all¿.The patient reported that an ambulance was called and attended at around 3 a.M., on (b)(6) 2022, and that he was subsequently taken to the emergency room (e.R) where he remained for around ¿40-48 hours¿ before being released.The patient was unable to recall what treatment he received or what his blood glucose was measured at in the e.R, stating that he was unconscious and did not remember ¿anything else¿ beyond the ambulance attending.At the time of troubleshooting, the patient was unable and/or unwilling to confirm if the unit of measure was set correctly on the subject device at the time of testing.The patient was unable and/or unwilling to confirm if the test strip vial was intact; if the strips had been open beyond the discard date or if they had been stored correctly.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 which required an ambulance and treatment at the e.R.The alleged inaccuracy issue could not be ruled out as a cause and/or contributor to the event.

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.

Manufacturer Narrative

The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.Further analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.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 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: 14406174
• MDR Text Key: 291705976
• Report Number: 3008382007-2022-04309
• 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,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• 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: 4808316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention; Life Threatening