IMMULITE 2000 3GALLERGY SPECIFIC IGE
Received Dec 4, 2017 · Event occurred Nov 9, 2017
Report 2432235-2017-00630 · MDR key 7080222
Device
Generic name
Immulite 2000 3gallergy Specific Ige
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedModel number
IMMULITE 2000 3GALLERGY SPECIFIC IGELot number
602
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER. SYSTEM CALIBRATION AND QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. THE KIT STATUS WAS OVERDUE WHILE RUNNING THE SAMPLE IN QUESTION. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULTS FOR FP5 PANEL ON TWO PATIENT SAMPLES IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDRS 2432235-2017-00628 AND 2432235-2017-00629 WERE FILED FOR THE SAME EVENT.
Description of Event or Problem
DISCORDANT, FALSE NEGATIVE RESULTS WERE OBTAINED FOR 3GALLERGY SPECIFIC IGE FOR FOOD PANEL 5 (FP5) ON TWO PATIENT SAMPLES UPON INITIAL AND REPEAT TESTING, WHILE USING KIT LOT 602. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE SENT TO AN ALTERNATE LABORATORY, WHERE THEY WERE TESTED ON AN UNKNOWN PLATFORM, RESULTING POSITIVE. IT IS UNKNOWN IF THE RESULTS FROM ALTERNATE LABORATORY WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULTS.
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2017-00630 WAS FILED ON 04-DEC-2017. ADDITIONAL INFORMATION (05-DEC-2017): THE REPEAT TESTING IN THE ALTERNATE LABORATORY WAS PERFORMED ON AN ALTERNATE PLATFORM. THE RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). SECTION HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION. MDRS 2432235-2017-00628_S1 AND 2432235-2017-00629_S1 WERE FILED FOR THE SAME EVENT.
Description of Event or Problem
THE REPEAT TESTING IN THE ALTERNATE LABORATORY WAS PERFORMED ON AN ALTERNATE PLATFORM. THE RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S).
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2017-00630 WAS FILED ON 04-DEC-2017. THE FIRST SUPPLEMENTAL MDR 2432235-2017-00630_S1 WAS FILED ON 20-DEC-2017. 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. MDRS 2432235-2017-00628_S2, 2432235-2017-00629_S2, AND 2432235-2018-00095_S1 WERE FILED FOR THE SAME EVENT.