MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO FLEX METER; GLUCOSE MONITORING SYS/KIT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Loss of Vision (2139); Sweating (2444)

Event Type  Injury  

Event Description

On (b)(6), the lay user/patient contacted lifescan (lfs) alleging that her onetouch verioflex meter read inaccurately high in comparison to her feelings or normal results.The complaint was classified based on customer care advocate (cca) documentation.The patient could not specify when the meter issue occurred however stated that she obtained a result of ¿157 mg/dl¿ which she felt was inaccurately high.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine the possibility of inaccuracy.The patient manages her diabetes by self-adjusting her insulin doses and consumed less food or drink but did not specify when.The patient reported that 10 minutes before and after the allegedly inaccurate results she developed symptoms of ¿sweat and loss of sight¿ and self-treated with food or drink.During troubleshooting the cca noted that the meter was set to the correct unit of measure and the test strips had not expired or been stored incorrectly.The patient did not have control solution available to be able to perform a control test.Product was replaced and requested back.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury adverse event.Although the patient had developed symptoms prior to the issue occurring, it cannot be ruled out that the meter may have been reading inaccurately before the onset of symptoms and therefore could have caused or contributed to the event.

Manufacturer Narrative

The lay user/patients 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.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.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 FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6989574
• MDR Text Key: 90627195
• Report Number: 3008382007-2017-23011
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-3BBSA4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2017
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention