MAS CHEMTRAK H

MDR report key: 3999216 · Received July 30, 2014

Report

Report Number: 2937369-2014-00001
Event Type: Injury
Date Received: July 30, 2014
Date of Event: June 30, 2014
Report Date: July 29, 2014
Manufacturer: MICROGENICS CORP.
Product Code: JJY
PMA / PMN Number: K092051
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4) SELECTED AS PT HAS NOT REPORTED INFECTION WITH (B)(4).

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
445748	MAS CHEMTRAK H	CHEMTRAK H LIQUID ASSAYED CHEM CNTRL	JJY	MICROGENICS CORP.	NA	CHU14081

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention