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

Lot Number	4220218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Weakness (2145); Shaking/Tremors (2515)
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 read inaccurately high in comparison to results obtained on another meter.The complaint was classified based on customer care advocate (cca) documentation.The patient reported that on (b)(6) 2017 she obtained a result of ¿196 mg/dl¿ on the subject meter which she felt was inaccurately high in comparison to a reading of ¿179 mg/dl¿ obtained on another device.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.It is unknown what medication, if any, the patient takes to manage her diabetes or if she made any changes to her diabetes management routine.The patient reported that an unknown time after the alleged issue occurred she developed symptoms of ¿weak and shaking¿ however did not specify receiving any treatment.During troubleshooting the cca noted that meter was set to the correct unit of measure and an approved sample site was used.Product was replaced and requested back.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for 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: 6995610
• Report Number: 3008382007-2017-23072
• Device Sequence Number: 19155601
• Product Code: NBW
• UDI-Device Identifier: 00353885000512
• UDI-Public: (01)00353885000512
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/25/2017

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: 4220218
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2017
• Device Age: 3 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/02/2017
• 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