N
Patient 1
THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE CUSTOMER STATED THAT CALIBRATIONS AND QUALITY CONTROLS WERE ACCEPTABLE AT THE TIME OF THE SAMPLE RUN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.
MAUDE MDR 5351373
- MDR report key
- 5351373
- Report number
- 2247117-2016-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-11-30
- Date received
- 2016-01-07
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- CASSANDRA KOCSIS
- Address
- 511 BENEDICT AVENUE TARRYTOWN NY 10591 US
- Phone
- 914-914-9145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | IMMULITE 2000 XPI | IMMULITE 2000 XPI | SIEMENS HEALTHCARE DIAGNOSTICS INC. | LFZ | IMMULITE 2000 XPI | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-01-07 | 0 |
Event Narratives#
D
Patient 1
DISCORDANT, FALSE NON-REACTIVE CYTOMEGALOVIRUS IGG (CMV IGG) AND CYTOMEGALOVIRUS IGM (CMV IGM) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON THE SAME INSTRUMENT, RESULTING REACTIVE. THE ORIGINAL SAMPLE WAS THEN REPEATED ON THE SAME INSTRUMENT, ALSO RESULTING REACTIVE. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NON-REACTIVE CMV IGG AND CMV IGM RESULTS.
N
Patient 1
THE INITIAL MDR 2247117-2016-00002 WAS FILED ON JANUARY 07, 2016. ADDITIONAL INFORMATION (01/05/2016): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE PERFORMED A PREVENTIVE MAINTENANCE AND DID NOT FIND ANY INSTRUMENT MALFUNCTION. THE CAUSE OF THE DISCORDANT, FALSE NON-REACTIVE CMV IGG AND CMV IGM RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.