D
Patient 1
THE CUSTOMER RECEIVED QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXO IGG) RESULTS ON THEIR E601 ANALYZER. THE PATIENT WAS BEING MONITORED MONTHLY DURING HER PREGNANCY FOR TOXO IGG USING A VIDAS ANALYZER WITH NEGATIVE RESULTS,
MAUDE MDR 2274644
- MDR report key
- 2274644
- Report number
- 1823260-2011-05212
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-09-06
- Date received
- 2011-10-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NA JENNIFER WOLFGRAM
- Address
- 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
- Phone
- 317-317-3175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COBAS 6000 E601 MODULE | IMMUNOCHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | LJK | NA | 04745922001 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-10-04 | 0 |
Event Narratives#
N
Patient 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE EVENT OCCURRED IN (B)(6).
N
Patient 1
THE PATIENT HAD NEGATIVE TOXO IGG RESULTS ON A VIDAS ANALYZER FOR THE PREVIOUS EIGHT MONTHS.
N
Patient 1
THE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. REACTIVE/POSITIVE RESULTS WERE OBTAINED. THE POSITIVE TOTO IGG RESULT IS REGARDED AS CORRECTLY POSITIVE. THE PATIENT WAS NOT HARMED.