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

Lot Number	4511322
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Sweating (2444)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the patient contacted lifescan usa, alleging that her onetouch ultra mini meter was reading inaccurately erratic.The following complaint was classified based on limited information customer service representative (csr) managed to obtain from patient before she discontinued the call.Csr noted that she was unable to identify when the alleged issue began.The patient alleged that she obtained blood glucose readings of "300, 264 and 100 mg/dl" on the subject meter, performed within 20 minutes of each other.Based on statistical methodology these readings exceed lifescan's criteria for precision.It is unknown how the patient manages her diabetes or if any changes were made to her normal diabetes management regimen.The only information made available to the csr was that after the product issue she had developed symptoms of "sweating".It is unknown if the alleged symptoms required any treatment.During troubleshooting the csr noted this was not the first time the product was being used, there was no obvious misuse of the meter, the correct test strips were being used, and the patient described the correct testing steps.The csr confirmed that the patient's test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms that may be suggestive of a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: ONE TOUCH ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, ; SZ
• MDR Report Key: 8878455
• Report Number: 2939301-2019-02439
• Device Sequence Number: 1978348
• Product Code: NBW
• UDI-Device Identifier: 00353885000512
• UDI-Public: 00353885000512
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019
• Report Date (Section F): 08/09/2019

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: 4511322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/02/2019
• Event Location: Home
• Date Report to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• 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
• Date Report Sent to FDA: 08/09/2019