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

Lot Number	4360470
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Fainting (1847); Vertigo (2134)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter displayed inaccurately high results compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation following a review of the call by a senior cca.The patient reported that the subject meter was reading inaccurately between 10pm and 11pm on (b)(6) 2019, when she obtained alleged inaccurately high blood glucose results of ¿315 and 276 mg/dl¿ on the subject meter, compared to ¿167 and 137 mg/dl¿ on a bayer contour meter.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 insulin which she self-adjusts.She reported that after obtaining the ¿high¿ readings, she administered an additional 2 units of fast acting insulin.She reported that around midnight on (b)(6), she ¿lost balance and passed out¿.She stated that her husband called the paramedics, a blood glucose result of 26 mg/dl was obtained on the er/hospital meter.She indicated that she was treated with a shot of unknown medication from the healthcare professionals and was admitted to the intensive care unit for observation.During troubleshooting, the cca confirmed that the subject meter was set to the correct unit of measure.The cca documented that the patient had used an approved sample site; however, her testing steps were incorrect as she had used the same puncture site to obtain the blood for the reported comparisons.Education was provided by the cca and replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and symptoms suggestive of a serious injury adverse event requiring medical intervention, after obtaining alleged inaccurately high blood glucose results on the subject meter and administering increased insulin.

• 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: 8694579
• Report Number: 3008382007-2019-02109
• Device Sequence Number: 13911101
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/04/2019

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: 4360470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2019
• Device Age: 67 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/13/2019
• 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: Hospitalization; Life Threatening; Required Intervention