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

Lot Number	4342037
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	Nausea (1970)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the reporter contacted lifescan (b)(4) alleging that his wife¿s onetouch ultra 2 meter was reading inaccurately erratic.The following complaint was classified based on information obtained from customer service representative (csr) documentation.The reporter alleged that, they first became aware of the product issue on (b)(6) 2018, at 6 pm, when his wife obtained blood glucose readings of ¿170 and 567 mg/dl¿ on the subject meter, performed within 20 minutes of each other.Based on statistical methodology these readings exceed lifescan¿s criteria for precision.The reporter stated that his wife manages her diabetes using insulin (self-adjuster), and that she made no changes to her normal diabetes management, in response to the alleged inaccurate readings.The reporter stated that 15 mins prior to the meter issue, the patient had developed symptoms of ¿nausea¿.The reporter stated that his wife attended the hospital, and was treated by a health care professional, with ¿10 shots of humalog and lantus insulin¿, at 6.10 ¿ 6.15 pm on the same day.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure, the correct testing steps were being followed, and the patient had used an approved sample site to obtain the blood samples.The csr confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The csr noted the patient did not have control solution.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, while using the product, which required treatment by a health care professional and the alleged meter issue could not be ruled out as a cause or contributor to the event.
Additional 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 ULTRA2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7439111
• Report Number: 3008382007-2018-01160
• Device Sequence Number: 11026830
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: 00353885008853
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 4342037
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 50