MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORPORATION PROTIME 3 CUVETTE ASSAY; TEST, TIME, PROTHROMBIN

Model Number PRO3-4

Device Problem Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/10/2012

Event Type  malfunction  

Event Description

The patient was reportedly self-monitoring for warfarin therapy using a protime microcoagulation instrument and test cuvettes.The patient's therapeutic range was 2.0-3.5 inr.On (b)(6) 2012, the patient's protime result was 3.7 inr.The patient reportedly experienced rectal bleeding on (b)(6) 2012.On (b)(6) 2012, the patient's reference lab result was a 6.4 inr.The patient was hospitalized and treated with vitamin k and transfusion of 4 units of packed cells.The patient was discharged from the hospital on (b)(6) 2012.

Manufacturer Narrative

(b)(4).Method: actual device not evaluated.Result: no results available since no evaluation performed.Conclusion: manufacturing deficiency.Neither the manufacturer nor the distributor has records of any performance associated complaints reported by customer prior to this report.Manufacturer notified fda on 09/20/2012 of protime 3 cuvettes voluntary recall.Protime 3 cuvettes within a specified lot range may recover lower than expected prothrombin time/international normalized ratio (pt/inr) results.Itc's investigation into the product's performance identified increased imprecision in addition to an increase negative bias corresponding to manufacturing changes.Recall #z-0837-2013 was terminated by the fda on 03/25/2014.Itc has requested all data required for form 3500a.

• Brand Name: PROTIME 3 CUVETTE ASSAY
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORPORATION; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 8 olsen ave.; edison, NJ 08820 ; 7325485700
• MDR Report Key: 4174470
• MDR Text Key: 5156123
• Report Number: 2248721-2014-00033
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2013
• Device Model Number: PRO3-4
• Device Catalogue Number: PRO3-4
• Device Lot Number: B2P3C047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0837-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 111