MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	3952311
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Lethargy (2560)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter read inaccurately high compared to her feelings and/or normal readings and inaccurately erratic.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2017 at 10:30 am.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿323, 230, 236, 208 and 291 mg/dl¿ with the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient also reported obtaining blood glucose readings of ¿174, 115, 131, 160, 179, 323, 230, 236, 208 and 291 mg/dl¿ with the subject meter, performed more than 20 minutes apart.The time difference between the results exceeds lfs¿ criteria for a valid comparison.The patient manages her diabetes with insulin (self-adjuster).The patient stated that she took action of consuming less food and drink from when the alleged issue began until contacting lfs.The patient informed the csr that an unspecified time after the alleged issue started she became ¿drowsy.¿ the patient denied receiving any medical treatment.During troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter.The csr noted that the patient was testing with test strips that had expired.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event after obtaining alleged inaccurate results with the subject meter.

• Brand Name: OT ULTRA2 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: 6774220
• Report Number: 3008382007-2017-22119
• Device Sequence Number: 10800569
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: (01)00353885008853
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/05/2017

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: 3952311
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2017
• Device Age: 32 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2017
• Initial Report FDA Received Date: 08/08/2017
• 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
• Patient Age: 71 YR
• Patient Weight: 126