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

Lot Number 4412558

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

Patient Problems Syncope (1610); Twitching (2172)

Event Date 09/26/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that the his onetouch verio iq meter displayed inaccurate high results compared to his feelings/normal results.The complaint was classified based on additional information obtained by the customer service representative (csr) during the follow up call with the patient.The patient stated that the alleged meter inaccuracy began around (b)(6) 2018, although no blood glucose readings were reported at the indicated time.The patient informed the csr that on (b)(6) 2018, during the day, he obtained high blood glucose readings of ¿240 and 231 mg/dl¿ on the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient manages his diabetes with insulin administered on a sliding scale (humolin nph and humolin r, unspecified dose).The patient stated to test 4 to 6 times a day and to adjust his medication according to the results (for high results the patient will take 2-3 additional units of humolin r and for low results, he will eat some sugar).The patient¿s usual blood glucose level range is ¿120-185 mg/dl¿.In response to the alleged high results, the patient denied making any changes to his usual diabetes management regimen instead he confirmed to ¿eat less food¿ during the day.The patient reported that on (b)(6) at 2:00 am he developed symptom of ¿jerking¿ and he declared that, at the time of the reported symptoms, he was ¿not conscientious enough¿.During the follow up call, the patient stated that his wife tried 3 times to ¿get him stable¿, treating the patient with some food which was "spitted out" by the patient.At the arrival of the emergency medical services (ems) at around 2:00 am, the patient was treated with ¿iv fluid, patches and sweet oral solution in a tube¿.The patient felt better afterwards, and his blood glucose level was checked, obtaining results of ¿136-138 mg/dl¿.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure and the strips had not been open longer than the discard date, had not expired, and had been stored correctly.The patient did not have control solution to test the meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after ¿eating less food¿ based on the alleged inaccurate high results obtained with the subject meter.

Manufacturer Narrative

The lay user/patients meter 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.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 IQ 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
• MDR Report Key: 7963465
• MDR Text Key: 123670438
• Report Number: 3008382007-2018-02854
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (y/n): Y
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 4412558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2018
• Device Age: 26 MO
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/13/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73