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

Model Number 022-659

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

Patient Problems Syncope (1610); Hypoglycemia (1912); Dizziness (2194); Sweating (2444); No Code Available (3191)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio2 meter was reading inaccurately high compared to another device (onetouch ultramini).This complaint was classified based on information obtained from the customer care agent (cca) during the initial call since the patient refused to provide additional information when contacted by the cca.The patient reported that the alleged inaccuracy issue began when he first got the device on an unknown date in 2018.The patient was unable to recall results obtained with the subject device but reported that on (b)(6) 2020, he obtained alleged elevated readings which in response to; he phoned his doctor who in turn, changed his medication from metformin (500 mg, three times a day) to pioglitazone (15 mg).The patient advised that the following day, on (b)(6) 2020, he developed symptoms of "hypoglycemia", feeling "dizziness, sweating, heart stress" and reported that he felt like he "was going to pass out".It is not known if the patient self-treated these symptoms; however, he stated that he contacted his doctor again to advise of the symptoms he developed and stated that in response, his doctor changed his prescription of pioglitazone, increasing the dose from 15 mg to 30 mg.The patient advised that he continued to have these symptoms and that latterly, on an unspecified date, his doctor advised him to stop using the subject device due to possible inaccurate results.It is not known if the patient treated or received treatment for the symptoms that he associated with hypoglycemia or if any further changes were made to his prescribed medication, beyond (b)(6) 2020.The patient reported that he performed several comparison tests on the subject device and a onetouch ultramini between (b)(6); reportedly obtaining blood glucose results of "141, 95, 185, 134 and 152 mg/dl" on the subject device compared to "107, 79, 162, 104 and 113 mg/dl" obtained on the other meter.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly at the time of testing, that an approved sample site was used to obtain the results and that the patient was following the correct testing procedure.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.The cca also noted that at the time of the call, the patient did not have control solution available to test the subject system.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after obtaining alleged elevated blood glucose results on the subject device.The alleged inaccuracy issue could not be ruled out as a cause and/or contributor to the event.

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 has passed performance testing with no faults found.The reported issue could not be confirmed.A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.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: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10488010
• MDR Text Key: 205507779
• Report Number: 3008382007-2020-03995
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (y/n): N
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 022-659
• Device Lot Number: 4592422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening