N
Patient 1
THIS EVENT OCCURRED IN (B)(6).
MAUDE MDR 5534898
- MDR report key
- 5534898
- Report number
- 1823260-2016-00376
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-10-26
- Date received
- 2016-03-30
- 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 MICHAEL LESLIE
- 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 | CMV IGM, IGM ANTIBODIES TO CYTOMEGALOVIRUS | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | ROCHE DIAGNOSTICS | LFZ | NA | 04784618160 | 182962 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-03-30 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER QUESTIONED RESULTS FOR 21 PATIENTS TESTED FOR IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) AND IGG ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGG). ERRONEOUS CMV IGM OR CMV IGG RESULTS WERE IDENTIFIED FOR 14 PATIENTS. THE ERRONEOUS RESULTS FOR WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER CMV IGM. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CMV IGG ERRONEOUS RESULTS. PATIENT 1 INITIAL CMV IGM RESULT FROM THE E601 ANALYZER WAS 0.386 COI (NEGATIVE). THE REPEAT RESULT FROM THE MINI VIDAS ANALYZER WAS 1.88 (POSITIVE) AND THE REPEAT RESULT FROM THE ARCHITECT I 1000 WAS 1.93 (POSITIVE). PATIENT 1 INITIAL CMV IGG RESULT FROM THE E601 ANALYZER WAS
N
Patient 1
THE SAMPLES FOR PATIENT 1 FROM (B)(6) 2015 AND (B)(6) 2016 WERE SUBMITTED FOR INVESTIGATION. THE RESULTS FROM THE CUSTOMER WERE CONFIRMED DURING THE INVESTIGATION. THE SAMPLES WERE TESTED BY THE ROCHE METHOD AND THE MIKROGEN RECOMLINE METHOD. THE ROCHE RESULTS AND RECOMLINE RESULTS WERE COMPARABLE. BOTH THE ROCHE ASSAY AND THE RECOMLINE ASSAYS DO NOT DETECT SIGNIFICANT (B)(6) SPECIFIC IGM TITERS IN THE SAMPLES. FOR THIS PATIENT, A SEROCONVERSION FOR IGM WAS NOT DETECTED. MISSING THE IGM SEROCONVERSION OF A PATIENT WITH 2 INDEPENDENT ASSAYS AT THE SAME TIME IS RARE BUT CANNOT BE EXCLUDED FOR THIS PATIENT. THE SAMPLE FOR PATIENT 2 FROM (B)(6) 2016 WAS SUBMITTED FOR INVESTIGATION. THE SAMPLES WERE TESTED BY THE ROCHE METHOD AND THE MIKROGEN RECOMLINE METHOD. THE CUSTOMER RESULTS COULD NOT BE CONFIRMED DURING THE INVESTIGATION. (B)(6) IGG ANTIBODIES WERE DETECTED IN BOTH THE ROCHE CMV IGG ASSAY AND THE RECOMLINE CMV IGG ASSAY AND FOUND TO BE OF HIGH AVIDITY. THE HIGH AVIDITY OF THE DETECTED IGG ANTIBODIES INDICATES A REMOTE INFECTION WITH (B)(6). WHEN SAMPLES ARE OBTAINED DURING THE DECLINING PHASE OF THE IGM RESPONSE, ASSAYS FROM DIFFERENT MANUFACTURERS ARE LIKELY TO PRODUCE DISCREPANT RESULTS; HOWEVER, A RELIABLE DIAGNOSIS OF THE (B)(6) STATUS CAN BE OBTAINED BY ASSESSING THE IGG STATUS IN COMBINATION WITH THE IGG AVIDITY. A GENERAL DECLINE OF THE (B)(6) IGM RESULTS WAS NOT CONFIRMED. INTERNAL QUALITY ASSURANCE PRIOR TO PRODUCT RELEASE AND REAL TIME MONITORING FOLLOWING PRODUCT RELEASE GUARANTEE CONSTANT PERFORMANCE. COMPARATIVE MEASUREMENTS MINIMIZE PERFORMANCE VARIANCE BETWEEN DIFFERENT LOTS.
N
Patient 1