MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP; GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE

Model Number	53399
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient impact was reported.Nova biomedical received medwatch report #(b)(4) in the mail on (b)(6) 2018 regarding the alleged deficiency on the statstrip glucose hospital meter.Nova had not been previously made aware of the incident, contrary to the medwatch report, as the customer only reported battery issues during their call with nova technical support on (b)(6) 2018.During this call, nova agreed to replace the meter under warranty and requested the return of the device via rma# (b)(4).Nova was unable to contact the original reporter but did speak with the poc coordinator at banner estrella, bonny carpenter, who had reported the battery issue.She was able to confirm that the statstrip meter was noted as being inconsistent compared to another device but could not confirm if qc was checked before or after the incident.She stated that she was unaware the event had been reported to medwatch and that she had incomplete records of the incident because their internal escalation process had not been properly followed.Ms.Carpenter stated that the event was reported to risk management and that the meter was returned to the poc office but she was unable to power it on.She said that she only reported the battery issue to nova technical support because there was little detail and no adverse event related to the incident.A device history record (dhr) review is currently being performed by the senior quality control manager and an internal investigation will be opened when the meter is received.
Event or Problem Description
Customer reported that patient glucose results from the statstrip meter appeared to be inconsistent and higher than expected.The operator then used a second meter and recovered lower results more in line with what was expected.

• Brand Name: STATSTRIP
• Common Device Name: GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• MDR Report Key: 8073618
• Report Number: 1219029-2018-00007
• Device Sequence Number: 13817951
• Product Code: CGA
• UDI-Device Identifier: 00385480533997
• UDI-Public: 00385480533997
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: No Information
• Device Model Number: 53399
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 111