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

Lot Number	4396507
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Nausea (1970); Hot Flashes/Flushes (2153); Dizziness (2194)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter displayed inaccurately erratic results.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that the subject meter started reading inaccurately at an unknown time on (b)(6) 2018; however, she was unable to recall the results.The patient manages her diabetes with janumet 50/1000mg oral medication.She denied making any changes to her usual diabetes management routine as a result of the alleged issue ; she indicated that she stuck to her diet and exercised.She reported that an unknown time after obtaining the alleged inaccurately erratic results, she developed symptoms of ¿nauseous, dizzy, light headed and hot flashes¿.She reported that during a doctor¿s office visit her doctor did ¿nothing¿ as he/she was trying to figure out what was wrong.No other treatment for the symptoms was reported.At the time of troubleshooting, the cca noted that the subject meter was set to the correct unit of measure.The patient did not have control solution to test the meter and test strips.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms suggestive of a serious injury adverse event, after obtaining alleged inaccurately erratic blood glucose results on the subject meter.
Additional Manufacturer Narrative
The lay user/patients 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.Lifescan also 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.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.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: 7760840
• Report Number: 3008382007-2018-02246
• Device Sequence Number: 16583648
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 08/02/2018

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: 4396507
• 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: 08/02/2018
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/08/2018
• 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