MAUDE Adverse Event Report: MICROTYPING SYSTEMS ORTHO PROVUE; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number MTS213784

Device Problems Bent (1059); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

Fe was able to correct specification back in range to 108, and customer successfully ran and accepted qc.Repairs have returned the instrument to expected operation.A complaint review for this customer's provue serial number (b)(4) was performed in qerts dra#359096.As per dra#359096 - complaint review time frame from 8-20-15 to 10-16-15.Results: total of 5 complaints as follows; probe impact 1, provue software 1, reagent carousel 1, stability failure in motor y 1, zgelcam outspec - 1 complaint (phse (b)(4) - the subject of this assessment).One emdr - (b)(4) (this event).The investigation determined that the most likely root cause of this event was human error of the fe to correctly follow ortho provue reader camera procedures.One of the action items for this issue is to provide all provue trained fe¿s with awareness training on the camera image system settings.Nonconformance #(b)(4) has been opened to investigate the camera out of specification issue.The investigation determined that the most likely root cause of this event was an out of specification provue camera setting.

Event Description

(b)(6) contacted cts to report an on-site to investigate a bent probe complaint, field engineer decided to perform mod 41.When performing mod 41 he found the reader camera is out of range, and the camera brightness is set to 132.

• Brand Name: ORTHO PROVUE
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): MICROTYPING SYSTEMS; 1295 southwest 29th avenue; pompano beach FL 33069
• Manufacturer Contact: marta carnielli ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 5223370
• MDR Text Key: 31452917
• Report Number: 1056600-2015-00097
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MTS213784
• Device Lot Number: 3.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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