MAUDE Adverse Event Report: CLARITY MEDICAL SYSTEMS, INC. RETCAM 3; OPHTHALMIC CAMERA

Model Number RETCAM 3

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem Not Applicable (3189)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

When the doctor (located in (b)(6)) was creating a new patient record in the retcam system, she noticed that the calculated age of the patient appeared wrong.Patient was not injured.Patient age is calculated at the time of retcam use based on patient's date of birth.Patient age is provided for reference information only.Physicians do not typically rely on retcam calculated age to determine start of screening and/or follow up examinations for monitoring retinopathy of prematurity (rop).In this case, the doctor was not using the retcam displayed age to determine the date for initial or follow up rop screening.However, in the very unlikely scenario that a medical professional relies on the age of the patient as displayed on the retcam system for initiation of screening, he might start rop screening later than recommended (up to 2 weeks in the worst case).Failure to timely screen and proactively treat (if deemed medically necessary) might result in permanent impairment of vision.Note that there have been no previous reports of this issue to date.This software is installed on over (b)(4) devices/been in field for 2 yrs.

Manufacturer Narrative

Clarity was able to duplicate the issue using devices in-house with a similar software configuration; software version 6.2.The retcam ophthalmic imaging system calculates age which is displayed on the retcam system computer monitor in days, weeks, and/or months.The error occurs only in the "weeks" value.Internal tests show that if the patient is born november 1 to december 31, the patient's displayed age may appear as much as 2 weeks less than the actual age.For all other patient's (born january 1 to october 31), the patient's displayed age may appear as much as 1 week less than the actual age.The root cause of the problem is a software anomaly in software versions 6.0, 6.1, and 6.2.Clarity currently intends to issue a user safety letter followed by provision of a software patch.Clarity risk analysis based upon typical hospital work flow and post market information indicates that an injury due to this software anomaly is improbable to remote.Hospitals typically use hospital erm systems to determine patient age.There are over (b)(4) devices in the field with this anomaly.Initial distribution of retcam version 6 devices began in november 2011.This is the first and only report clarity has received regarding this software anomaly.

• Brand Name: RETCAM 3
• Type of Device: OPHTHALMIC CAMERA
• Manufacturer (Section D): CLARITY MEDICAL SYSTEMS, INC.; pleasanton CA 94588
• Manufacturer Contact: gary seeger ; 5775 west las positas blvd.; pleasanton, CA 94588
• MDR Report Key: 3670061
• MDR Text Key: 4343058
• Report Number: 2952489-2014-00001
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RETCAM 3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 14 DA
• Patient Weight: 2