MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM

Model Number	GLU TEST STRIP
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Nova biomedical (nova) was made aware of a potential issue regarding analysis of glucose results during the treatment of a patient while using an unidentified nova statstrip glucose meter.The user indicated the meter did not recognize the disposable test strip of lot 0321069249 when inserted.Another test strip from the same vial was used which also was not recognized by the meter.A second vial of test strips was used of an unknown lot and the meter recognized these strips when inserted and provided a result.No patient harm or adverse treatment due to the lack of results was reported.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Additional Manufacturer Narrative
Udi: (b)(4).No product was returned to nova biomedical for investigation.The manufacturer retains of the test strip lot: 0321069249 were tested using five retained meters.The test strips were used during analysis of multiple samples.During this usage, the reported error was not seen with the retained strips and the reported problem could not be reproduced.Device history record (dhr) reviews were performed for the test strips being used at the time of the event by a quality control investigator.The reviews included an assessment of the production, testing, and release of the meter and test strips.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be reproduced after testing the retained test strips.A conclusive root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

• Brand Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 14077827
• Report Number: 1219029-2022-00022
• Device Sequence Number: 19356908
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: GLU TEST STRIP
• Device Catalogue Number: 42214
• Device Lot Number: 0321069249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown