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 Codes	Headache (1880); Nausea (1970); Dizziness (2194)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, the lay user/patient contacted lifescan (lfs), alleging that her onetouch ultra mini meter displayed inaccurately erratic results.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that the subject meter started reading inaccurately erratic on (b)(6) 2019, 11:30pm.She reportedly obtained alleged inaccurately erratic blood glucose results of ¿145, and 95mg/dl¿, performed less than 20 minutes apart.Based on statistical methodology, the calculated difference between the reported results, exceeds lfs¿ precision criteria.The patient stated that half an hour prior to obtaining these readings she experienced the symptom of ¿headache , nausea and dizziness¿.The patient manages her diabetes with diet and exercise and reported that she self treated with food ¿strawberry flavoured yogurt and fruits¿.The patient denied that she used another device to obtain a blood glucose result.At the time of troubleshooting, the cca noted that the subject meter was set to the correct unit of measure and the samples had been taken from the same approved sample site.The patient described the correct testing steps.She confirmed that her test strips were within expiry date and had been stored correctly in an intact vial.The patient was not in possession of control solution to perform a test.Replacement products were sent to the patient.Based on the information provided, there is no indication that the subject meter caused or contributed to a serious injury adverse event.The patient had become symptomatic prior to attempting.The patient did not develop signs/symptoms suggestive of a serious injury, nor did she receive medical intervention for an acute blood glucose excursion.However, this complaint is being reported as a malfunction because the calculated difference between the reported results falls outside lfs¿ precision criteria and the alleged inaccuracy was not resolved during troubleshooting.

• 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: 8630788
• Report Number: 3008382007-2019-01692
• Device Sequence Number: 1643778
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): N
• 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): 05/20/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2019
• Device Age: 62 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 68