IMMULITE 2000 3GALLERGY SPECIFIC IGE
Received May 22, 2018 · Event occurred Apr 24, 2018
Report 2432235-2018-00207 · MDR key 7533663
Device
Generic name
Immulite 2000 3gallergy Specific Ige
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedModel number
IMMULITE 2000 3GALLERGY SPECIFIC IGECatalog number
L2KUN6
Lot number
601
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
A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE KIT RELEASE DATA FOR THE LATEST LOT (KIT LOT 602) AVAILABLE FOR IMMULITE 2000 3GALLERGY SPECIFIC IGE RESULTS FOR RAT EPITHELIUM ALLERGEN (E73), WHICH SHOWED THAT THE ALLERGEN IS PERFORMING AS EXPECTED. THE HSC SPECIALIST CONCLUDED THAT THE POTENTIAL CAUSE OF THE DISCORDANT RESULTS COULD BE DUE TO THE SAMPLE SPECIFIC ISSUE. THE DEVICE IS PERFORMING AS EXPECTED. NO FURTHER EVALUATION OF DEVICE IS REQUIRED. MDR 2432235-2018-00206 HAS BEEN FILED FOR THE SAME EVENT FOR ALLERGEN E87 WHICH HAS DIFFERENT 510(K) # OF K021206.
Description of Event or Problem
DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULT FOR RAT EPITHELIUM ALLERGEN (E73) (510 (K) # K013134) WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING AN UNKNOWN KIT LOT. THE SAMPLE WAS ALSO TESTED NEGATIVE FOR RAT ALLERGEN (E87) (510 (K) # K021206). THE SAMPLE WAS REPEATED ON AN ALTERNATE PLATFORM FOR ALLERGENS E87 AND E73, RESULTING POSITIVE. IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3GALLERGY SPECIFIC IGE RESULTS.
Description of Event or Problem
DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULT FOR RAT EPITHELIUM ALLERGEN (E73) (510 (K) # K013134) WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 601.
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2018-00207 WAS FILED ON 22-MAY-2018. ADDITIONAL INFORMATION (04-JUN-2018): THE KIT LOT USED TO TEST THE PATIENT SAMPLE IN QUESTION FOR 3GALLERGY SPECIFIC IGE, RAT EPITHELIUM ALLERGEN (E73) WAS LOT 601. UPON FURTHER REVIEW OF DATA, SIEMENS DETERMINED THAT ALLERGENS FROM THE SAME GENUS ARE EXPECTED TO CROSS-REACT AS IN THE CASE OF RATTUS RATTUS (BLACK RATS) AND RATTUS NORVEGICUS (BROWN RATS). SECTIONS B5 AND D4 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION. MDR 2432235-2018-00206_S1 HAS BEEN FILED FOR THE SAME EVENT FOR ALLERGEN E87 WHICH HAS DIFFERENT 510(K) # OF K021206.