N
Patient 1
DEVICE NOT RETURNED TO MANUFACTURER.
MAUDE MDR 5365077
- MDR report key
- 5365077
- Report number
- 3002769706-2016-00008
- Event key
- 0
- Event type
- 3
- Date received
- 2016-01-13
- 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
- MR. RYAN LEMELLE
- Address
- 595 ANGLUM ROAD HAZELWOOD MO 63042 US
- Phone
- 314-314-3147
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VIDAS? MUMPS IGG ASSAY | VIDAS? MUMPS IGG ASSAY | BIOMERIEUX SA | LJY | 30218 | 1003758900 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-01-13 | 0 |
Event Narratives#
D
Patient 1
A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANCY IN RESULTS WITH THE VIDAS MUMPS IGG TEST. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMERIEUX THAT THE ASSOCIATED RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. SUBMITTAL OF THE PATIENT SAMPLE HAS BEEN REQUESTED. BIOMERIEUX INVESTIGATION WILL BE INITIATED.
N
Patient 1
BIOM?RIEUX INTERNAL INVESTIGATION WAS CONDUCTED. HOWEVER, THE CUSTOMER DID NOT COMPLY WITH BIOM?RIEUX REQUEST FOR SAMPLE SUBMITTAL AND THE REFERENCED PRODUCT LOT WAS ALREADY EXPIRED. ANALYSIS OF THE MANUFACTURING QC BATCH RECORD FOR THE REFERENCED LOT INDICATED NO ABNORMALITY. AS INDICATED IN THE INSTRUCTIONS FOR USE, VIDAS MUMPS IGG PERFORMANCE DOES NOT CLAIM 100% IN TERM OF SPECIFICITY OR SENSITIVITY. VIDAS MUMPS IGG AND ARUP USE DIFFERENT TESTING METHODS; THEY ARE QUALITATIVE ELFA TEST AND SEMI-QUANTITATIVE CHEMILUMINESCENT TEST, RESPECTIVELY. WITHOUT THE ARUP PERFORMANCE SPECIFICATIONS (SENSITIVITY AND SPECIFICITY) AND THE LACK OF THIRD CONFIRMATORY METHOD, IT IS NOT POSSIBLE TO DETERMINE WHICH RESULT IS CORRECT. THE INVESTIGATION CONCLUDED THAT NO PRODUCT PERFORMANCE ISSUE WAS CONFIRMED FOR THE REFERENCED LOT OF VIDAS MUMPS IGG ASSAY.