MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONE TOUCH VERIO2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4469143

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Collapse (2416)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) (b)(4), alleging a product usability issue with a onetouch verio 2 meter purchased in (b)(6).The complaint was classified based on the customer care advocate (cca) documentation and additional information obtained during a follow-up call with the patient on july 26, 2019.The patient reported that she had purchased the onetouch verio 2 meter when she had been in (b)(6) about 10 days prior to contacting lfs.She stated that she had not realized that the unit of measure in (b)(6) differed from that used in (b)(6) meters.She indicated that at 7:57am on (b)(6) 2019, she obtained a blood glucose result on the meter of 229 mg/dl which she interpreted as 22.9 mmol/l.The patient manages her diabetes with novorapid and tresiba insulin.She reported that based on the misinterpreted result, she administered 5 units of novorapid.She stated that an unspecified time later, she "collapsed" and was "admitted to hospital".She reported that blood glucose tests were performed at the hospital, but she did not know any of the results obtained.The patient denied receiving any treatment for her symptom either before or during hospitalization.The issue was resolved during troubleshooting and a replacement meter in mg/dl was sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event necessitating admittance to hospital (but not medical treatment for the symptom), after purchasing a meter in mg/dl, misinterpreting the result as mmol/l, and administering excess insulin due to the misinterpreted result.

• Brand Name: ONE TOUCH VERIO2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 8844724
• MDR Text Key: 152746424
• Report Number: 2939301-2019-02425
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/31/2019

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: 4469143
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Home
• Date Report to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 47 YR