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

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a reporter on behalf of the lay user/patient contacted lifescan(lfs) usa alleging that the patient¿s onetouch ultramini meter was reading inaccurately high compared to another meter.The following complaint was classified based on information obtained from the customer service representative (csr) documentation.It was reported that the alleged inaccuracy began on (b)(6) 2018 at around 10-11:30 am.The reporter claimed that the patient got a value of ¿104 mg/dl¿ with the subject meter compared to a result of ¿40 mg/dl¿ with an emergency medical service (ems) meter.The tests were performed at the same time.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 manages her diabetes with a combination of medications; metformin twice daily, trulicity 180 units once a week and an unspecified injection for her diabetes.It was not reported if the patient made any changes to her usual diabetes management routine due to the alleged inaccuracy issue.The reporter claimed that one-hour prior to obtaining the alleged inaccurate result, the patient had developed a symptom of feeling ¿really tired¿ and it was reported that after obtaining the result of ¿40 mg/dl¿ with the ems¿s meter, the patient was taken to the emergency room where she was treated with iv fluids and glucose to raise her blood sugar.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure and the patient had used an approved sample site to obtain the blood samples.In addition, based on the information provided, the patient was following the correct testing procedure.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.The patient did not have control solution to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while using the product.Although the patient¿s symptoms occurred prior to them obtaining the alleged inaccurate result, the alleged meter issue could not be ruled out as a cause or contributor to the 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: 8109600
• Report Number: 3008382007-2018-03275
• Device Sequence Number: 11241182
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 11/19/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2018
• Device Age: 37 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/28/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 113