MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM; LACTATE MONITOR

Model Number 1.0

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2021

Event Type  malfunction  

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Event Description

On august 30, 2021, nova biomedical (b)(4) was made aware of a potential issue regarding imprecise lactate results on a fetal patient while using a stat strip lactate meter, serial number (b)(4), and lactate test strips, lot 2620345249.The user questioned the results during obstetric surgery and found more bias in the meter results compared to those from a blood gas analyzer.

Manufacturer Narrative

Udi: (b)(4).The customer reported an incorrect patient result for lactate was received when running a patient sample on a statstrip meter sn (b)(6).This occurred on (b)(6) 2021.The meter did not indicate there was a problem with the sample in anyway before producing the result.The customer indicated a cesarean section (c-section) was performed based off the results provided but was uncertain if the c-section would have been unnecessary without those results.The meter was returned to nova biomedical for investigation.The meter was tested with manufacturer retains of the strips with lot 2620345249.All tests passed the acceptance criteria for linearity solutions and blood samples when compared to five additional meters.No discrepancies were observed between blood results obtained by the retained test strips on the returned meter when compared to the reference ysi analyzer.Device history record (dhr) reviews were performed for the meter and the strip lot 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 noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be confirmed after testing the returned meter and the manufacturer retains of the strips.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Event Description

On august 30, 2021, nova biomedical canada was made aware of a potential issue regarding imprecise lactate results on a fetal patient while using a stat strip lactate meter, serial number (b)(6), and lactate test strips, lot 2620345249.The user questioned the results during obstetric surgery and found more bias in the meter results compared to those from a blood gas analyzer.It was later communicated a cesarean section (c-section) was performed because of the uncertainty of the results from the meter in an effort to mitigate potential harm to fetus or the mother.The user stated the c-section may have been unnecesary but proceeded based off the results from the meter.No additional patient information is available.

• Brand Name: NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
• Type of Device: LACTATE MONITOR
• 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: 12547983
• MDR Text Key: 274834029
• Report Number: 1219029-2021-00037
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 00385480474887
• UDI-Public: 00385480474887
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.0
• Device Catalogue Number: 47488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other