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

Lot Number	4304317
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Sweating (2444)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa alleging that a lancing device was missing from her kit.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the issue with the lancing device occurred on (b)(6) 2017 at 3.44 pm.He reported that he manages his diabetes with insulin(self-adjuster) and he administered his normal amount of medication (novolog 14 units).The patient alleged that on the day the lancing device issue began he developed symptom of ¿sweaty¿.No treatment was required for the alleged symptom.During troubleshooting the csr noted that the lancing device was missing from the package, and the closure seal on the packaging was intact, prior to opening.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 the alleged product 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: 7141471
• Report Number: 3008382007-2017-23714
• Device Sequence Number: 1145089
• Product Code: NBW
• UDI-Device Identifier: 00353885000482
• UDI-Public: 00353885000482
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 4304317
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1