MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS AXOXIMETER 4000; SPECTRAL ABSORB. CURVE, OXYHEMOGLOBIN, CARBOXYHEMOGLOBIN, CARBON MONOXIDE

Model Number	AVOX4000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr references accriva diagnostics' complaint number (b)(4) for avoximeter 4000 co-oximeter serial number (b)(4).A child case capturing the cuvette and lot number of the disposable device tested with this instrument is 7053171-31711 and is referenced by accriva diagnostics' complaint number (b)(4).Actual device not evaluated.Process evaluation was performed.Dhr reviewed showed no ncrs, capas, instrument repairs or other anomalies related to this complaint.Results: no results available since no evaluation performed.Conclusion: device not returned.Accriva has requested all data required for form fda 3500a.
Event or Problem Description
Healthcare professional reported an unexpectedly high %cohb result with an avoximeter 4000 co-oximeter in a continuously ventilated nursing home patient.Blood gases and co-oximetry tests were being conducted every 12 hours.Test results were as expected except for one unexpectedly high %cohb result (5.2%) that was clinically significant and above the patient's 48-hour baseline %cohb of 2.1%.The patient received an unspecified treatment and subsequent blood gases and co-oximeter results returned to baseline.An internal investigation did not find any evidence that the patient was exposed to carbon monoxide.No medical complications or other events were reported.
Additional Manufacturer Narrative
Correction: patient weight was not specified - please delete the (b)(6) value previously entered.
Event or Problem Description
Follow-up #2.
Additional Manufacturer Narrative
Mdr 2250033-2018-00004 follow-up #1 references acriva diagnostics' complaint number (b)(4) for avoximeter 4000 co-oximeter serial number (b)(4), which was evaluated in response to the customer's complaint.(b)(4).Accriva diagnostics has requested all data required for form fda 3500-a.No previously unobtainable information reported in the initial mdr is available.
Event or Problem Description
Follow-up #1.

• Brand Name: AXOXIMETER 4000
• Common Device Name: SPECTRAL ABSORB. CURVE, OXYHEMOGLOBIN, CARBOXYHEMOGLOBIN, CARBON MONOXIDE
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7173967
• Report Number: 2250033-2018-00004
• Device Sequence Number: 1173675
• Product Code: JKS
• UDI-Device Identifier: 10711234530054
• UDI-Public: 10711234530054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

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: AVOX4000
• Device Catalogue Number: AVOX 4000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 03/11/2018; 03/11/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 04/10/2018; 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVOX4000 QV8 CUVETTES
• Patient Age: 66 YR
• Patient Weight: 60