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 Nausea (1970); Vomiting (2144); Abdominal Cramps (2543)

Event Type  Injury  

Event Description

On (b)(6) 2017, the reporter (mother) for the patient contacted lifescan (lfs) alleging that her daughters onetouch verio flex meter was reading inaccurately low compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation.The reporter detailed that the alleged issue first began on (b)(6) 2017, in the morning.In the first week of (b)(6) 2017, the patient obtained an alleged glucose result of 35mg/dl on the subject meter compared to 127 mg/dl on the other meter.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The reporter stated that the patient manages her diabetes with insulin (self-adjuster) and was immediately given food (carbs) by the reporter (mother) in response to the alleged product issue.The reporter stated on and unspecified time later that day the patient developed symptoms of ¿abdominal pain, nausea and vomiting¿.The patient was then admitted to hospital and was given an anti-nausea medicine (zofran) by an hcp.The reporter was not able to specify the diabetes treatment that was administered to the patient.At the time of trouble shooting, the cca confirmed that the subject meter was set to the correct unit of measure, the sample was taken from an approved sample site and the correct testing steps were used.The reporter confirmed that the test strip vial was not cracked or broken and the test strips were stored correctly and within expiry date.The reporter did not have control solution to perform a test.Replacement products were sent to the patient and requested back for evaluation.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury adverse event after the alleged product issue began and reportedly received hcp intervention as a result of the alleged product issue.

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.Lifescan also conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7040067
• MDR Text Key: 92284615
• Report Number: 3008382007-2017-23275
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: (01)00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2017
• Device Age: 15 MO
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2016
• 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): Hospitalization