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

Model Number	022-657
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hypoglycemia (1912); Coma (2417)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay-user/patient's spouse contacted lifescan (lfs) (b)(4), alleging that the patient's onetouch verio2 meter read inaccurately high compared to another device (emergency medical services' meter).The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred on (b)(6) 2020 at 8:00 am.The reporter claimed the patient obtained blood glucose readings of "114 mg/dl" with the subject meter then "29 mg/dl" on the other device, performed more than 30 minutes apart.The patient manages their diabetes with a fixed daily dose of 60 units of lantus insulin.The reporter denied the patient made any changes to their usual diabetes management regimen as a result of the alleged issue.The reporter claimed that 1 hour after the alleged issue occurred, the patient developed a "diabetic coma" and the emergency medical services (ems) were notified for assistance.When ems arrived, the reporter claimed the patient was treated with a glucagon injection followed by jam and was then was transported to hospital where they remained until 3:00 pm.The reporter claimed the patient's blood glucose tested "29 mg/dl" on the ems device, prior to treatment.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical treatment for an acute low blood glucose excursion after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional 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.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.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.Similar complaints for this issue were trended for the subject test strip lot, lot# 4608681.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.The lay user/patient also retuned a vial of ot verio test strips not associated with this complaint, lot# 4583105.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 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10885167
• Report Number: 3008382007-2020-04053
• Device Sequence Number: 19606682
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 022-657
• Device Catalogue Number: 022-657
• Device Lot Number: XBMFR1KJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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; Required Intervention