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

Model Number	54794
Medical Device Problem Codes	Non Reproducible Results (4029); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported patient harm or intervention.There is currently a pending investigation.The device is being returned to nova biomedical for this investigation.Additional information and further details will be provided in a supplemental report.
Event or Problem Description
Nova biomedical (nova) was made aware of a potential issue regarding discrepant glucose results using a statstrip 1.86 hospital meter, serial no.(b)(4) and glucose test strips, lot no.0319163249.It was reported that glucose discrepancies for heelstick test were observed for a neonate patient.No inappropriate treatment was started and the patient was not adversely affected by the result.
Additional Manufacturer Narrative
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).A customer reported neonatal glucose result discrepancy for heel stick samples.Statstrip 1.86 meter, sn(b)(6) , using statstrip glucose test strips, lot 0319114309, reported an initial patient glucose result of 2.6 mmol/l and the 2.0 mmol/l upon repeat, a second and third time.The sample was then repeated on a different meter which reported 2.2 mmol/l.Customer reported that meter passed qc l1, lot 0419025301, and l3, lot 0419050303, but specified that internal procedure does not require additional qc after inconsistent results, they are just performed daily, and device cannot be used if qc fails.The meter in question was removed from use after the discrepant results and returned to nova biomedical (nova) for testing.Device history record (dhr) reviews for the statstrip 1.86 meter, sn (b)(6), and glucose test strips, lot 0319114309, were performed by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter and test strip batch.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.Retained glucose test strips, lot 0319114309, met all performance acceptance criteria and no discrepant results were observed, even when tested with the returned statstrip 1.86 meter, sn (b)(6).The complaint was not able to be reproduced.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.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 a preventive action.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 no root cause was able to be identified.Nova will continue to monitor for recurrence, no further action is required at this time.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 11504490
• Report Number: 1219029-2021-00004
• Device Sequence Number: 3459544
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2021

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: 54794
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021; 05/07/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/12/2021; 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA