MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRAMINI METER; GLUCOSE MONITORING SYS/KIT

Lot Number	4439075
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dizziness (2194); Sweating (2444); Confusion/ Disorientation (2553)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(4) 2018, 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 and additional information obtained following a review of the call by a senior cca.The patient reported that the meter had been reading inaccurately for about 3 months prior to contacting lfs.She alleged that on an unspecified date/time, she obtained an alleged inaccurately high blood glucose result of ¿119 mg/dl¿ on the subject meter compared to ¿ below 30 mg/dl¿ on an emergency medical services (ems) meter, performed greater than 30 minutes apart.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 alleged that on an unspecified date/time her husband found her ¿out of it, sweaty and dizzy¿.She indicated that her husband twice gave her orange juice and then called the rescue service when the reported result of ¿below 30 mg/dl¿ was obtained.The patient was unsure what treatment, if any, was provided by ems.At the time of troubleshooting, the patient confirmed that the meter had been set to the correct unit of measure.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, i.E.Out of it, sweaty, and dizzy with and ems result of below 30 mg/dl, after obtaining alleged inaccurately high blood glucose results on the subject meter.

• Brand Name: OT ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7800298
• Report Number: 3008382007-2018-02336
• Device Sequence Number: 1637799
• Product Code: NBW
• UDI-Device Identifier: 00353885000512
• UDI-Public: 00353885000512
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/11/2018

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
• Device Lot Number: 4439075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2018
• Device Age: 47 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2018
• Initial Report FDA Received Date: 08/21/2018
• 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