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

Lot Number 4807442

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

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

On (b)(6) 2022, lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio reflect meter was reading inaccurately high compared to their feelings and/or normal readings.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call.The patient reported that the alleged inaccuracy issue began at an unspecified time on the evening of (b)(6) 2022.The patient claimed obtaining a blood glucose reading of ¿200 mg/dl¿ with the subject device which they felt was inaccurately high compared to their feelings and/or normal results.The patient manages their diabetes with insulin (unspecified type and dose) and reported that in response to the alleged elevated reading obtained on the subject device, they ¿took more insulin¿; however, the patient was unable to specify the type of insulin or dose administered at the time.The patient reported that they then ¿fainted while on the bus¿.The patient was unwilling to provide further information relating to the event.It is not known whether the patient received medical treatment as a result of the alleged issue.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly at the time of testing.The patient was unable and/or unwilling to continue with product troubleshooting and so it is therefore not known if the test strip vial was intact, if the test strips had been stored properly or open beyond their discard date.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event for an acute low blood glucose excursion after administering an increased dose of insulin based on the alleged elevated reading obtained on the subject device.

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.

• 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: 15255550
• MDR Text Key: 298197177
• Report Number: 3008382007-2022-04335
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193475
• 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: 08/18/2022

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: 4807442
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/18/2022
• 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