ELECSYS IGE II IMMUNOASSAY
Received Aug 30, 2019 · Event occurred Aug 5, 2019
Report 1823260-2019-03183 · MDR key 8950666
Device
Generic name
Radioimmunoassay, Immunoglobulins (d,e)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04827031190
Lot number
379919
Product problems
- Low Test Results
- Low Test Results
Patient
35
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED BASED ON THE ACCEPTABLE QC. THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT THE CUSTOMER DECLINED TO PROVIDE THE SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULTS FOR 1 PATIENT TESTED ON A COBAS 6000 E 601 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 2491 IU/ML ON THE E 601. THE SAMPLE WAS TESTED IN A DIFFERENT LABORATORY AND THE RESULTS WERE >3000 IU/ML AND 6000 IU/ML. THE INSTRUMENTS USED WERE SIEMENS AND ABBOTT. THE INSTRUMENT THAT WAS USED FOR EACH SPECIFIC RESULT WAS NOT PROVIDED. ON 10-AUG-2019 A NEW SAMPLE WAS COLLECTED AND THE RESULT WAS 2207 IU/ML ON THE E 601. THE RESULT WITH A 1:5 DILUTION WAS 6274 IU/ML ON THE E 601. ON 16-AUG-2019 THE SAMPLE WAS REPEATED WITHOUT DILUTION AND THE RESULT WAS 2452 IU/ML WITH A DATA FLAG ON THE E 601.