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

Model Number	023-927
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Dyspnea (1816); Diaphoresis (2452)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio reflect meter read inaccurately erratic.The complaint was classified based on further information obtained by the customer care agent (cca) during a follow-up call with the patient.The patient reported that when she went to bed on (b)(6) 2021 at 1:20 am, she felt very bad; she reported symptoms of ¿sweating and suffocation.¿ in response to how she was feeling, the patient claimed she tested her blood glucose with the subject meter and obtained alleged inaccurate readings of ¿55, 101, 102 then 110 mg/dl,¿ performed more than 20 minutes apart.The patient claimed that when the reading of ¿55 mg/dl¿ was obtained, she started to treat herself with sugar water/coca cola and continued to eat/drink until 3:30 am when she fell asleep; however, the patient denied feeling better after treatment.During the follow-up call, the patient claimed she associated the reported symptoms with a high blood glucose excursion; the symptoms were typical for her when running high.The patient manages her diabetes with a combination of insulin (toujeo 20 units once daily; humalog three times a day).The patient also explained that for 15 days prior to the alleged issue, she hadn¿t felt well, but denied making any changes to her usual diabetes management routine; she ate and took insulin in proportion to what her blood sugar was.The patient informed the cca that she attributed the reported symptoms on (b)(6), 2021 to having eaten more than usual at lunch (even ice cream) and to very hot weather.During troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and reportedly administered inappropriate self-treatment based on alleged inaccurate results obtained with the subject meter.
Additional Manufacturer Narrative
This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.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 REFLECT METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12351557
• Report Number: 3008382007-2021-04215
• Device Sequence Number: 5190472
• Product Code: NBW
• UDI-Device Identifier: 00353885011693
• UDI-Public: 00353885011693
• Combination Product (Y/N): Y
• PMA/510(K) Number: K193475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 023-927
• Device Lot Number: 4745675
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening