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

Lot Number	4106904
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Codes	Visual Impairment (2138); Weakness (2145); Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio iq meter was reading inaccurately high, compared to another meter (onetouch ultra 2).The complaint was classified based on customer service representative (csr) documentation, and further information obtained when medical surveillance specialist reviewed the initial call.The patient reported that he first became aware of the alleged meter issue began on (b)(6), at 3.15 pm, alleging that he obtained an inaccurately high blood glucose reading of ¿192 mg/dl¿ with the subject meter compared to ¿88 mg/dl¿ on another meter, performed within 30 minutes of each other.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 reported that he manages his diabetes using insulin (self-adjuster) and he made no changes to his normal diabetes management regimen.The patient reported that ten minutes prior to him becoming aware of the alleged meter issue he had developed symptoms of ¿blurred vision, shaky and weak¿, in response to the symptoms he carried out the blood glucose tests.He reported self-treating the symptoms with an emergency glucose drink.During troubleshooting, it was established that the patient¿s meter was set to the correct unit of measure.She described the correct testing steps and the sample was taken from an approved sample site.The patient was using the correct test strips, and the strips had not been open longer than the discard date, had not expired, and had been stored correctly.The test strip vial was not noted to be cracked or broken.The csr noted the patient did not have control solution to test the subject meter.The products were requested back for evaluation and replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event that may have occurred after the alleged product issue began.
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 and test strips have passed all testing with no faults found.The reported issue could not be confirmed.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 VERIO IQ 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: 6471104
• Report Number: 3008382007-2017-16409
• Device Sequence Number: 18983883
• Product Code: NBW
• UDI-Device Identifier: 00353885007719
• UDI-Public: (01)00353885007719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110637
• 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
• Report Date (Section B): 03/31/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 4106904
• Other Device ID Number: 1-1960Z86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/31/2017
• Device Age: 7 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/17/2017
• 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