MAUDE Adverse Event Report: MICROGENICS CORP. MAS CHEMTRAK H; CHEMTRAK H LIQUID ASSAYED CHEM CNTRL

Catalog Number CHU-1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/30/2014

Event Type  Injury  

Event Description

A laboratory tech at (b)(6) hosp located at (b)(6) reported cutting their finger on a vial broken during handling.The laboratory tech was wearing gloves at the time of the incident, no sutures were required.The cause of the vial breakage is undetermined.The complaint also reported that the laboratory tested the remaining vial contents using vitros 5600 and obtained results (b)(6) for (b)(6).The customer generated (b)(6) results when performing secondary testing using the (b)(6) test.Lab tech began preventative medical treatment for (b)(6).Manufacturer testing was completed on july 08 for the retained samples as well as returned unused product from the customer.Testing occurred at (b)(4), an affiliate of thermofisher scientific, on the abbott architect (b)(6) assay and the procleix ultrio combo system.The results displayed no (b)(6) for (b)(6) from both systems.The customer sent the product for western blot testing with (b)(6) results for (b)(6) on all bands.The date for the testing is unk.No product malfunction has been asserted or identified.

Manufacturer Narrative

(b)(4) selected as pt has not reported infection with (b)(4).

• Brand Name: MAS CHEMTRAK H
• Type of Device: CHEMTRAK H LIQUID ASSAYED CHEM CNTRL
• Manufacturer (Section D): MICROGENICS CORP.
• Manufacturer Contact: dave wurtz ; 46360 fremont blvd; fremont, CA 94538 ; 5109795169
• MDR Report Key: 3999216
• MDR Text Key: 21317930
• Report Number: 2937369-2014-00001
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: CHU-1
• Device Lot Number: CHU14081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention