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

Lot Number	3952304
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	Loss of consciousness (2418)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 01/09/2017, 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 customer care advocate (cca) documentation.The patient stated that the alleged inaccuracy occurred at 6pm on (b)(6) 2017.At this time the patient obtained a blood glucose result of ¿104mg/dl¿ with the subject meter and ¿33mg/dl¿ on another meter within 30 minutes of one another.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for accuracy.The patient manages their diabetes by self-adjusting their insulin dosage and did not state whether they had taken any action with regard to their normal diabetes management regimen as a result of the alleged product issue.The patient stated that an unspecified period of time before the alleged inaccuracy occurred they were ¿unresponsive¿ and as a result were taken to the emergency room (e.R).In e.R they were treated with food and/or drink by a healthcare professional and the blood glucose result of ¿33mg/dl¿ was obtained at this time.At the time of troubleshooting the cca noted that the unit of measure was set correctly on the subject meter and the patient did not have control solution available to walk through a control solution test.The patient¿s products were replaced and requested for evaluation.This complaint is being reported because the patient claims to have obtained an inaccurately high reading on the subject meter which may have caused/contributed to the fact that the patient developed signs and symptoms indicative of a serious injury reportable adverse event.It cannot be said with absolute certainty that the alleged ¿inaccurately high¿ subject meter result did not affect treatment options prior the onset of these symptoms.
Additional Manufacturer Narrative
The lay user/patient¿s meter and test strips 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.The test strips passed all testing with no faults found.The reported issue could not be confirmed.Lifescan conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.
Additional Manufacturer Narrative
This supplemental is being sent to include information that was omitted from follow-up # 1.The following information was available at the time of submission of follow-up # 1 and should have therefore been included: section should have stated yes section should have stated yes and included date (b)(6) 2017 these fields have been updated.

• 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: 6255418
• Report Number: 3008382007-2017-02502
• Device Sequence Number: 955822
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: (01)00353885002684
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 3952304
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2017
• Device Age: 33 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 03/24/2017; 03/24/2017
• 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: 74 YR
• Patient Weight: 86