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

Model Number	1.0
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample has not been returned to nova as of yet; therefore, an evaluation of the device could not be performed.Further investigation is being completed and a supplemental report will be submitted upon completion.
Event or Problem Description
The ed educator reported that they had a pediatric patient with questionable nova statstrip glucometer results.The test was run march 02nd on their statstrip meter s/n: (b)(4) using test strips with lot: 0321243249.The patient was in diabetic ketoacidosis and then had blood sugars in a lower-than-expected range on one of the glucometers.When they tested on an alternate glucometer later in the evening, the blood sugar was in the range (176) that matched the clinical picture.
Additional Manufacturer Narrative
(b)(4).Dhr review for the statstrip glucose meter, sn (b)(6) was performed by the sr.Quality control investigator.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.Retain statstrip glucose test strips, lot 0321243249, met the performance acceptance criteria for linearity and whole blood specimens.All linearity results were within range and no discrepant results were observed for whole blood samples.No further action is required at this time, nova will continue to monitor for recurrence.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454
• Manufacturer Contact: shalomy mathew ; 200 prospect st; waltham, MA 02454 ; 7816473700
• MDR Report Key: 13981132
• Report Number: 1219029-2022-00016
• Device Sequence Number: 2382143
• Product Code: CGA
• UDI-Device Identifier: 00385480517072
• UDI-Public: 00385480517072
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K132121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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 Model Number: 1.0
• Device Catalogue Number: 51707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female