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

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dysphasia (2195); Loss of consciousness (2418)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa alleging that their onetouch ultramini meter read inaccurately high compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient stated that the alleged product issue occurred at 10:30pm on (b)(6) 2018.At this time, the patient obtained a blood glucose result of ¿181mg/dl¿ with the subject meter and ¿54mg/dl¿ on another device within 30 minutes of one another.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 their diabetes with 5mg glipizide per day and did not make any changes to their diabetes management regimen as a result of the alleged product issue.The patient developed symptoms of ¿incoherent and unresponsive¿ 10 minutes later.In response to this the emergency medical services (ems) were called.At 10:45pm the patient¿s blood glucose was measured on the ems meter with the result of ¿54mg/dl¿ being obtained at this time.In response to this the patient was given an iv from the ems.At the time of troubleshooting, the cca noted that the patient did not have control solution available to walk through a control solution test.The unit of measure was set correctly.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event after obtaining allegedly inaccurate high results with the subject meter.
Additional Manufacturer Narrative
The lay user/patients meter have been returned and evaluated by lifescan product analysis with the following findings: the meter passed all testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 7741745
• Report Number: 3008382007-2018-02193
• Device Sequence Number: 1398466
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 07/30/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2018
• Device Age: 49 MO
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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