FDA Adverse Event Malfunction Summary report: N

DRDQ 2 TEST SSP UNITRAY KIT

MDR report key: 3558182 · Received October 15, 2013

Report

Report Number: 2244574-2013-00060
Event Type: Malfunction
Date Received: October 15, 2013
Report Date: October 3, 2012
Manufacturer: LIFE TECHNOLOGIES
Product Code: MZI
PMA / PMN Number: BK020068
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS ISSUE IS THE SAME ISSUE AS DOCUMENTED UNDER CUSTOMER COMPLAINT (B)(4). (B)(4) CONTAINS THE INVESTIGATION AND CORRECTIVE ACTION DETAIL FOR THIS COMPLAINT (B)(4). THE INTERNAL INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE SEROLOGICAL TYPE (EQUIVALENT) ERROR WAS DUE TO A "BUG" FOUND IN THE HOS (HUMAN OLIGOTYPING SYSTEM) SOFTWARE WHICH ADDED EXTRA CHARACTERS "B1" INTO THE SEROLOGICAL TYPES. THE "BUG" IN THE SOFTWARE RESULTED IN DISCREPANCY WITH SEROLOGICAL EQUIVALENTS LISTED IN THE LABELING OF THE DRDQ 2 TEST SSP UNITRAY KIT (CATALOG # 7840010, LOT NUMBER 029 1103788). THE INCORRECT TYPING MAY HAVE LED TO A DELAY IN PATIENT RESULT REPORTING. A MANUAL CORRECTION TO THE HOS SOFTWARE WAS MADE TO REMOVE THE EXTRA CHARACTERS "B1" FROM THE SEROLOGICAL EQUIVALENT IDENTIFICATION. KIT DOCUMENTATION WAS UPDATED TO SHOW THE CORRECT SEROLOGICAL TYPES. CUSTOMER NOTIFICATIONS REGARDING THE CORRECTION WERE DISTRIBUTED AND KIT DOCUMENTATION WAS UPDATED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE INITIAL AND FINAL REPORT.

Description of Event or Problem · 1

TIFFANY PRESTON WITH INLAND NORTHWEST BLOOD CENTER INDICATED THAT THE SEROLOGICAL ASSIGNMENTS WITH THE DRDQ 2 TEST SSP UNITRAY KIT WERE INCORRECT WHEN THE (B)(4) UPDATE WAS USED. (CATALOG # 7840010, LOT NUMBER 029 1103788). (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
529452	DRDQ 2 TEST SSP UNITRAY KIT		MZI	LIFE TECHNOLOGIES		029 1103788

Patients

Seq	Age	Sex	Outcome	Treatment
1