MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4077859

Device Problems Calibration Error (1078); Incorrect Or Inadequate Test Results (2456)

Patient Problems Dizziness (2194); Shaking/Tremors (2515)

Event Date 09/04/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter was set to the incorrect calibration code number and read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter issues began on (b)(6) 2017 at around 7:00 am.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿380 and 180 mg/dl¿ with the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine the possibility of inaccuracy.The patient stated that she manages her diabetes with oral medication, diet and exercise and denied making any changes to her usual diabetes management regimen in response to the alleged issues.The patient reported that on (b)(6) 2017, about 6 days after the alleged issue began, she developed symptoms of feeling ¿lightheaded, shaky and dizzy.¿ the patient denied receiving any treatment beyond the usual routine of diabetes care and management in response to the symptoms.During troubleshooting, the csr confirmed the unit of measure was set correctly on the subject meter.The csr noted the patient was testing with test strips that had been stored correctly, were not expired or past their discard date.The csr noted the patient did not have control solution available to test the subject meter.The csr assisted the patient with changing the code number on the subject meter and the alleged calcode issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged meter issues began.The subject meter could not be ruled out as a cause or contributor 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.In addition, 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.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 ULTRA2 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: 6844255
• MDR Text Key: 84932594
• Report Number: 3008382007-2017-22428
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• 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: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4077859
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2017
• Device Age: 85 MO
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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