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

Model Number	022-657
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Memory Loss/Impairment (1958); Dysphasia (2195); Confusion/ Disorientation (2553)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio2 meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that on (b)(6) 2020 at 7:18 pm, she obtained what she felt was an inaccurate high blood glucose reading of "444 mg/dl" with the subject meter.The patient informed the cca that she manages her diabetes with oral medication (metformin 700 mg three times a day) and insulin (20 units novolog after lunch; 20-30 units of toujeo before bed based on food intake).When she obtained the elevated result, the patient claimed she took an extra dose of 20 units of novolog insulin.The patient claimed she retested her blood glucose with the subject meter and obtained results of "427, 371, 307 and 373 mg/dl" at 7:28 pm, 7:43 pm, 8:11 pm and 8:30 pm respectively.The patient stated that she began to develop symptoms of feeling "weak, no energy, lost memory, confusion and can't talk" at 8:30 pm.The patient claimed her daughter contacted the emergency room for assistance and was instructed to take her to hospital.However, the patient stated she consumed food as self-treatment for the symptoms; symptoms which lasted 1 hour.She claimed she felt better after treatment and slept until 6:30 am the next day.Prior to when the alleged issue occurred, the patient claimed she tested her blood glucose with the subject meter on (b)(6) 2020 at 3:51 pm and obtained a result of "84 mg/dl." the patient stated she thought she could last until the evening meal but since she was carrying out physical work, she started "shaking" after the physical effort.She took 10 g of grapes and a juice as self-treatment for the symptom.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted the patient was testing with test strips that were stored correct and were not expired or opened past their discard date.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 after taking extra insulin based on an alleged inaccurate high result obtained with the subject meter.
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 all testing with no faults found.The reported issue could not be confirmed.In addition, 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.However, 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.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: GLUCOSE MONITORING SYS/KIT
• Common Device Name: OT VERIO 2 METER
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10810149
• Report Number: 3008382007-2020-04045
• Device Sequence Number: 19708333
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/13/2020

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: 4655428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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
• Patient Age: 56 YR