MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRAMINI METER; GLUCOSE MONITORING SYS/KIT

Lot Number	4499711
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, the reporter contacted lifescan usa, alleging that the subject meter read inaccurately [high/low] compared to a laboratory device.The reporter claimed obtaining blood glucose readings of ¿91 mg/dl¿ with the subject meter and ¿71 mg/dl¿ on the laboratory device.The tests were performed within 10-30 minutes of each other.Between the tests there was no intervention that would be expected to change the blood glucose.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for accuracy.This complaint is being reported because the reported issue was not resolved with troubleshooting.There is no indication that the product caused or contributed to an adverse event.

• Brand Name: OT ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8685895
• Report Number: 3008382007-2019-02075
• Device Sequence Number: 2319465
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: 00353885002684
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 4499711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2019
• Device Age: 100 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1