MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON JR. CITRATE APTT CUVETTE

Catalog Number J103C

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Abdominal Pain (1685)

Event Date 11/11/2013

Event Type  malfunction  

Event Description

Healthcare professional reports results higher than reference laboratory with hemochron jr.Citrated aptt cuvette assay for pt with admitting diagnosis of abdominal pain and cholecystitis.Hemochron jr.Citrated aptt test generated result of 113 seconds, which was higher than the physician's expectations.Sample tested at the reference laboratory and result was 47.5 seconds.Pt management was based on the laboratory result.No adverse event(s) reported.

Manufacturer Narrative

(b)(4).Method: cuvette/single-use disposable.As part of itc's investigation, evaluation testing was performed on retain samples of a similar lot.Process evaluation performed.Review and trend analysis of finished product qc test data was performed.Manufacturing process reviewed.Result: an upward shift in non-heparinized blood response when compared to historical performance was identified.Conclusion: manufacturer notified fda on december 6, 2013 of the voluntary recall of (b)(4) lots of hemochron jr.Citrate aptt cuvettes.Itc's investigation into the product's performance identified that the affected lots of j103c cuvettes may recover higher than expected results in normal individuals.When testing non-heparinized (e.G.Normal blood samples), results may average higher than historic values.Test results performed on patients receiving heparin therapy are not affected.The upward shift in non-heparinized blood response is associated with a recent formulary optimization.Correction of the normal range shift being implemented to assure that test results from non-heparinized sampled in future lot releases will perform similar to historic experiences.

• Brand Name: HEMOCHRON JR. CITRATE APTT CUVETTE
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 20 corporate place south; piscataway, NJ 08854 ; 7325485700
• MDR Report Key: 3787201
• MDR Text Key: 4432952
• Report Number: 2248721-2014-00004
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: J103C
• Device Lot Number: E3JCC014-P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2250033-12/06/13-002
• Patient Sequence Number: 1
• Patient Age: 69 YR