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

Lot Number	4088504
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Codes	Dizziness (2194); Sweating (2444); Shaking/Tremors (2515)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2017, the lay user/patient¿s wife (reporter), contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra mini meter was reading inaccurately erratic.The complaint was classified based on customer service representative (csr) documentation.The reporter stated that they first noticed the alleged meter inaccuracy issue around (b)(6) 2017, at 8/8.30 am, claiming that they obtained an inaccurate blood glucose result of ¿160, 180 and 39 mg/dl¿ on the subject meter, performed within 20 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results falls out with lfs¿ criteria for precision.The reported stated that the patient manages his diabetes with glyburide and janumet, and denies that he made any changes to his normal diabetes management regimen.The reporter stated that around 8/830 am, the patient had developed symptoms of ¿shaky, sweaty and dizzy¿, and when they tested their blood glucose they obtained the results above.The reporter stated that the patient self-treated the symptoms by drinking some pepsi.A blood glucose result of ¿140 mg/dl¿ was obtained on another meter on (b)(6) 2017, the time of this result is not known.During troubleshooting, it was established that the patient¿s meter was set to the correct unit of measure.The reporter 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, it is unknown when the meter issue began so the symptoms may have started 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.
Additional Manufacturer Narrative
This supplemental is being sent to include information that was omitted from follow-up #1.The lay user/patient's test strips have also been returned and evaluated by lifescan product analysis with the following findings: the test strips passed all testing with no faults found, the reported issue could not be confirmed.The 'alert date' of follow-up #1 should have stated: 4/7/2017 and has been updated appropriately.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: 6416256
• Report Number: 3008382007-2017-13174
• Device Sequence Number: 1013236
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: (01)00353885002684
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/10/2017

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: 4088504
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/19/2017
• Supplement Report FDA Received Date: 04/18/2017; 04/24/2017
• 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: 57 YR
• Patient Weight: 93