inforMED
MalfunctionDHB

IMMULITE 2000 3GALLERGY SPECIFIC IGE

Received Feb 26, 2018 · Event occurred Jan 29, 2018

Report 2432235-2018-00095 · MDR key 7297548

Device

Generic name

Immulite 2000 3gallergy Specific Ige

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Unknown

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE CAUSE OF THE DISCORDANT 3GALLERGY SPECIFIC IGE RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDRS 2432235-2017-00628, 2432235-2017-00629 AND 2432235-2017-00630 WERE FILED FOR THE SAME ISSUE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAVE OBTAINED DISCORDANT RESULT FOR 3GALLERGY SPECIFIC IGE ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLE GAVE POSITIVE RESULT FOR FOOD PANEL 5 (FP5) AND NEGATIVE RESULT FOR F2 (MILK), WHICH IS PART OF THE FP5 PANEL. IT IS UNKNOWN IF THE SAMPLE WAS REPEATED. IT IS UNKNOWN WHICH RESULT WAS CORRECT AND WHICH RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3GALLERGY SPECIFIC IGE RESULT.

Additional Manufacturer Narrative

THE INITIAL MDR WAS FILED ON 26-FEB-2018. SUPPLEMENTAL MDR WAS FILED ON 06-APR-2018. CORRECTED INFORMATION (06-APR-2018): THE INFORMATION PROVIDED IN THE MDR LABELED AS MDR SHOULD HAVE BEEN PROVIDED AS MDR. SECTION G7 HAS BEEN UPDATED ACCORDINGLY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (13-MAR-2018): THE SAMPLE COULD NOT BE PROVIDED FOR IN-HOUSE TESTING. IN ADDITION, THERE WAS NO LIST OF MEDICATIONS PROVIDED THAT THE PATIENT MAY HAVE TAKEN AT THE TIME OF TESTING THAT COULD BE REVIEWED AS A POSSIBLE INTERFERENT. THE KIT RELEASE INFORMATION DEMONSTRATED THAT THE DEVICE IS PERFORMING AS EXPECTED. A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED THE EVENT INFORMATION AND SUSPECTS THE CAUSE OF THE EVENT TO BE DUE TO THE SAMPLE SPECIFIC ISSUE. UPDATED WITH THE RESULT AND CONCLUSION CODES. MDRS 2432235-2017-00628_S2, 2432235-2017-00629_S2, AND 2432235-2018-00630_S2 WERE FILED FOR THE SAME EVENT.