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

Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	Loss of consciousness (2418)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra 2 meter read inaccurately high compared to another meter (paramedics meter).The complaint was classified based on the customer service representative (csr) documentation, and further information obtained on follow up call with patient.The patient reported that the alleged meter inaccuracy began the week prior to her contacting lfs (approximate date (b)(6) 2017).The patient reported obtaining an alleged inaccurate high blood glucose reading of ¿378 mg/dl¿ with the subject meter, compared to ¿28 mg/dl¿ on the other 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.The patient informed the csr that she manages her diabetes with insulin (self-adjuster), and that in response to the alleged high result, she administered 30 units of humalog insulin 500.It is not clear at what time, but the patient reported that after the administration of the insulin she became unconscious and her daughter had to call the paramedics.The patient was unwilling to answer any further questions, so it is not known what the treatment the patient received.During troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter, and that the patient¿s test strips had been stored correctly, were within expiry date.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 after the alleged product issue began.

• 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: 7124879
• Report Number: 3008382007-2017-23627
• Device Sequence Number: 16483322
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: 00353885008853
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2017
• Device Age: 38 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/18/2017
• 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
• Patient Age: 68 YR
• Patient Weight: 88