MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE® PRIME PLUS ANALYZER SYSTEM; WHOLE BLOOD HEMOGLOBIN ASSAYS

Model Number	Prime Plus
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Loss of consciousness (2418)
Date of Event	10/16/2021
Type of Reportable Event	Death
Event or Problem Description
Nova biomedical (nova) was made aware of a potential issue regarding missing co-oximetry results during the treatment of a patient on a statprofile prime plus analyzer with serial number (b)(4).It was reported the patient arrived intubated and was presumed to be intoxicated leading to severe methemoglobinemia.The prime plus analyzer did not produce co-oximetry results when running a sample and instead displayed a "results suspect" message.This sample was run on an additional analyzer which confirmed the "results suspect".After three attempts at running a sample, a methemoglobin value of 55% was received.Without confirmation of the diagnosis, the patient was treated based on clinical presentation.The patient later went into cardiac arrest and did not recover after cardiopulmonary resuscitation.
Additional Manufacturer Narrative
Udi: (b)(4).The distributor reported an incident where a co-oximetry result was not received while treating a time-sensitive patient with a statprofile prime plus analyzer, serial number (b)(4).This occurred on (b)(6) 2021.The analyzer did not produce a result and instead produced a message saying "results suspect".The customer indicated the lack of results delayed the confirmation of the patient's diagnosis over a 90 minute period.The patient was treated for severe methemoglobinemia but later suffered cardiac arrest and could not be revived.Device history record (dhr) reviews were performed for the analyzer and the consumables in use at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the analyzer and consumables.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 confirms the analyzer functioned appropriately.As stated in the instructions for use, the error code, "coox data suspect," displays when the analyzer is unable to accurately produce a test result because of a possible interferent within the sample.This suspicion was confirmed when the same, "data suspect," result was received on a reference analyzer using multiple samples from the same patient.The analyzer and consumables worked as intended by displaying this error code and not displaying an inaccurate result.Nova will continue to monitor for recurrence of similar events.

• Brand Name: STAT PROFILE® PRIME PLUS ANALYZER SYSTEM
• Common Device Name: WHOLE BLOOD HEMOGLOBIN ASSAYS
• 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: 12843935
• Report Number: 1219029-2021-00049
• Device Sequence Number: 19921167
• Product Code: GKR
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K200204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Prime Plus
• Device Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR
• Patient Sex: Male