MAUDE Adverse Event Report: I-SENS, INC. ASSURE PRISM BLOOD GLUCOSE SYSTEM; BLOOD GLUCOSE TEST SYSTEM

Model Number	530001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per exemption number e2016001.The meter and test strips involved in the incident were evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller is reporting high blood readings.Caller states that a co-worker was unresponsive and they did a blood test and received a 214.Doesn't know if the finger was cleaned for sure but assumes it was an alcohol wipe.The temperature was 71 degrees.They took him to the hospital five minutes later and they received a reading of 31 but she doesn't know if it was blood draw or finger stick.The patient did not take insulin before occurrence.She doesn't know what meds that the patient may be on.Meter is stored in truck in the back and kept warm.She is complaining that they have had other issues with these meters and doesn't trust the assure prism.I did explain that they are used in long term care facilities that do not have an issue.She wants to switch to a different meter.Caller was getting upset and uncooperative.The variance is 85.5% and falls within the c range of the parkes grid.Controls were used and results were in range.

• Brand Name: ASSURE PRISM BLOOD GLUCOSE SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul 06646, ; KS
• MDR Report Key: 6283413
• Report Number: 3005621222-2017-00001
• Device Sequence Number: 1106483
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Emergency Medical Technician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Emergency Medical Technician
• Device Expiration Date: 10/31/2017
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: MS21MAD8A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Distributor Facility Aware Date: 12/29/2016
• Device Age: 3 MO
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1