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

Model Number	54790
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported patient harm or intervention.There is currently a pending investigation.Additional information and further details will be provided in a supplemental report.
Event or Problem Description
The customer reported to the fda (uf/importer report #: (b)(4)) that on (b)(6) 2021 a patient had a bedside glucose test done.The blood was collected by the phlebotomist and ran on the units glucometer at the bedside.The results was 54.However, the blood was collected and tested in the lab was 68.The customer concern is that neonatal blood sugars that are different can require treatment based on the numbers.According to the customer, the patient was not adversely affected by the incident.
Additional Manufacturer Narrative
Additional and corrected information: b4, g6, h1, h2, h10.An investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.
Additional Manufacturer Narrative
Udi- (b)(4).The customer reported to the fda (uf/importer report #: 1002600000-2021-8001) a neonatal patient glucose result discrepancy while using their statstrip meter 1.86, on (b)(6) 2021.The blood was collected by the phlebotomist and ran on the units glucometer at the bedside.The customer stated that the nova meter generated a patient result of 54 but the lab result was 68, no patient impact was reported.During follow-up the customer provided two serial number (sn) of statstrip meter 1.86, (b)(6), and (b)(6) that is used at the clinic.The exact sn of the meter used was unable to be identified because the clinic uses both of their meters interchangeably.The customer was also unable to provide and test strip lot information.No materials were retuned for investigation and the test strip lot information was not provided.No further investigation was possible and no root cause was able to be identified.Device history record (dhr) reviews for the statstrip meter 1.86, (b)(6) and (b)(6),were performed by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meters.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.No further investigation was possible as the customer did not returned materials for evaluation and could not provide any test strip lot information.However, nova previously performed a comprehensive study on four (4) different lots of statstrip glucose test strips, ages 3, 6, 12, and 18 months.The study evaluated samples with low glucose concentrations and high hematocrit concentrations to simulate venous whole blood neonatal blood specimens.The data meets the fda's acceptance criteria with much of the comparative data within +/- 5 mg/dl of the reference method and most within +/-10 mg/dl.This type of variability is expected against central laboratory systems.This shows that with proper sample collection and handling the system reports accurate results.Based on the increased frequency of similar complaints, regarding neonatal results, nova also revised ifus (instructions for use) for the appropriate products to include additional guidance for site preparation and heel stick sample collection for neonates.This effort was completed via preventive action 5142.The conclusion of this investigation is that the reported issue of discrepant neonatal glucose results, reported and documented in complaint (b)(4), could not be confirmed and thus, no root cause was able to be identified.A capa(corrective and preventative action) is not required as a result of this investigation because the complaint was not able to be confirmed.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
• MDR Report Key: 11507891
• Report Number: 1219029-2021-00014
• Device Sequence Number: 4266268
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 04/22/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/14/2021; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1