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

Lot Number	4018747
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Polydipsia (2604)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultramini meter was not powering on.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter power issue began on (b)(6) 2017 (time not specified).The patient manages her diabetes using insulin (no adjustments) and reportedly continued with her usual diabetes management routine (34 units lantus, 16 ¿ 20 units humalog) after the reported issue began.The patient stated that she developed symptoms of ¿very dizzy, headache and very thirsty¿ on (b)(6) and in the morning of (b)(6) she felt ¿very sick¿ and visited the emergency room (er) where her blood glucose was measured using an er meter, although she stated she was not told the result.The patient reportedly received hcp treatment of 10 to 20 units of insulin in response to the reported event.At the time of troubleshooting, the csr confirmed that the meter battery did not require to be replaced; the correct test strips were being used; it was not the patient¿s first use of the product and there had been no misuse.Replacement products were sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

• Brand Name: OT ULTRAMINI 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: 7032005
• Report Number: 3008382007-2017-23232
• Device Sequence Number: 19295749
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: (01)00353885002684
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 4018747
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/09/2017
• Device Age: 42 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/15/2017
• 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